NDC 45802-490OTC monographFDA ANDA · ANDA074661

Naproxen Sodium

Active substance: Naproxen Sodium

FDA labeler: Padagis Israel Pharmaceuticals Ltd

50 formulations • 133 package configurations
All 183 registered NDCs — click to copy
In one line

Naproxen Sodium (Naproxen Sodium) NDC 45802-490 converts to 45802-0490-75 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 45802-490
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
45802-0490-75
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry

All registered strengths & packaging

Every registered strength and package for Naproxen Sodium, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
220 mg/10113-4368-620113-436800113-4368-621 BOTTLE in 1 CARTON (0113-4368-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-710113-436800113-4368-711 BOTTLE in 1 CARTON (0113-4368-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-750113-436800113-4368-751 BOTTLE in 1 CARTON (0113-4368-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-790113-436800113-4368-79400 TABLET, FILM COATED in 1 BOTTLE (0113-4368-79)
220 mg/10113-4368-820113-436800113-4368-821 BOTTLE in 1 CARTON (0113-4368-82) / 200 TABLET, FILM COATED in 1 BOTTLE (0113-4368-00)
Inner component0113-4368-000113-436800113-4368-00Inner component of kit (0113-4368-82)
220 mg/145802-490-7545802-49045802-0490-751 BOTTLE in 1 CARTON (45802-490-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/166715-5428-466715-542866715-5428-041 BOTTLE, PLASTIC in 1 CARTON (66715-5428-4) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
220 mg/137808-652-6237808-65237808-0652-621 BOTTLE in 1 CARTON (37808-652-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/137808-652-7137808-65237808-0652-711 BOTTLE in 1 CARTON (37808-652-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/111822-0788-411822-078811822-0788-041 BOTTLE, PLASTIC in 1 CARTON (11822-0788-4) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/111822-0788-511822-078811822-0788-0580 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0788-5)
220 mg/111822-0788-611822-078811822-0788-061 BOTTLE, PLASTIC in 1 CARTON (11822-0788-6) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/143598-072-0143598-07243598-0072-011 BOTTLE in 1 CARTON (43598-072-01) / 100 TABLET, COATED in 1 BOTTLE
220 mg/141250-313-8241250-31341250-0313-82200 TABLET, FILM COATED in 1 BOTTLE (41250-313-82)
220 mg/111822-6040-511822-604011822-6040-051 BOTTLE, PLASTIC in 1 CARTON (11822-6040-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
220 mg/111822-6040-611822-604011822-6040-061 BOTTLE, PLASTIC in 1 CARTON (11822-6040-6) / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
220 mg/111822-6040-711822-604011822-6040-07270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-6040-7)
220 mg/111822-6040-811822-604011822-6040-081 BOTTLE, PLASTIC in 1 CARTON (11822-6040-8) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
220 mg/111822-6040-911822-604011822-6040-091 BOTTLE, PLASTIC in 1 CARTON (11822-6040-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
220 mg/143598-071-0143598-07143598-0071-011 BOTTLE in 1 CARTON (43598-071-01) / 100 TABLET, COATED in 1 BOTTLE
220 mg/163868-830-2063868-83063868-0830-201 BOTTLE, PLASTIC in 1 CARTON (63868-830-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/143598-073-0143598-07343598-0073-011 BOTTLE in 1 CARTON (43598-073-01) / 100 TABLET, COATED in 1 BOTTLE
220 mg/169842-748-0869842-74869842-0748-0880 CAPSULE, LIQUID FILLED in 1 BOTTLE (69842-748-08)
220 mg/169842-748-1669842-74869842-0748-16160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69842-748-16)
220 mg/169842-748-2069842-74869842-0748-201 BOTTLE, PLASTIC in 1 BOX (69842-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/169842-748-3069842-74869842-0748-301 BOTTLE, PLASTIC in 1 BOX (69842-748-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/169842-748-4069842-74869842-0748-401 BOTTLE, PLASTIC in 1 BOX (69842-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/169842-748-5069842-74869842-0748-501 BOTTLE, PLASTIC in 1 BOX (69842-748-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/169842-748-8069842-74869842-0748-801 BOTTLE, PLASTIC in 1 BOX (69842-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/143598-074-0143598-07443598-0074-011 BOTTLE in 1 CARTON (43598-074-01) / 100 TABLET, COATED in 1 BOTTLE
220 mg/153345-042-0153345-04253345-0042-011 BAG in 1 BOX (53345-042-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG
220 mg/121130-061-0521130-06121130-0061-0550 TABLET in 1 BOTTLE (21130-061-05)
220 mg/121130-061-0921130-06121130-0061-0990 TABLET in 1 BOTTLE (21130-061-09)
550 mg/171205-631-1571205-63171205-0631-1515 TABLET in 1 BOTTLE (71205-631-15)
550 mg/171205-631-3071205-63171205-0631-3030 TABLET in 1 BOTTLE (71205-631-30)
550 mg/171205-631-6071205-63171205-0631-6060 TABLET in 1 BOTTLE (71205-631-60)
550 mg/171205-631-9071205-63171205-0631-9090 TABLET in 1 BOTTLE (71205-631-90)
220 mg/168016-056-4068016-05668016-0056-401 BOTTLE, PLASTIC in 1 CARTON (68016-056-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
375 mg/169420-1375-169420-137569420-1375-01100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1)
220 mg/157344-145-0157344-14557344-0145-011 BOTTLE, PLASTIC in 1 CARTON (57344-145-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC
220 mg/168210-4096-168210-409668210-4096-01365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1)
220 mg/155301-368-7155301-36855301-0368-711 BOTTLE in 1 CARTON (55301-368-71) / 50 TABLET, FILM COATED in 1 BOTTLE
550 mg/180425-0574-180425-057480425-0574-0130 TABLET in 1 BOTTLE (80425-0574-1)
550 mg/180425-0574-280425-057480425-0574-0260 TABLET in 1 BOTTLE (80425-0574-2)
550 mg/180425-0574-380425-057480425-0574-0390 TABLET in 1 BOTTLE (80425-0574-3)
220 mg/125000-141-0225000-14125000-0141-02160 CARTON in 1 BOX (25000-141-02) / 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE
220 mg/125000-141-1425000-14125000-0141-141000 TABLET in 1 BOTTLE, PLASTIC (25000-141-14)
220 mg/125000-141-2625000-14125000-0141-262 BAG in 1 BOX (25000-141-26) / 1600 TABLET in 1 BAG
220 mg/125000-141-3025000-14125000-0141-306 BAG in 1 BOX (25000-141-30) / 6500 TABLET in 1 BAG
220 mg/125000-141-4325000-14125000-0141-4310 TABLET in 1 BOTTLE (25000-141-43)
220 mg/125000-141-9825000-14125000-0141-981 BAG in 1 BOX (25000-141-98) / 32165 TABLET in 1 BAG
220 mg/125000-144-0225000-14425000-0144-02160 CARTON in 1 BOX (25000-144-02) / 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE
220 mg/125000-144-1425000-14425000-0144-141000 TABLET in 1 BOTTLE, PLASTIC (25000-144-14)
220 mg/125000-144-2025000-14425000-0144-204 BAG in 1 BOX (25000-144-20) / 6500 TABLET in 1 BAG
220 mg/125000-144-3025000-14425000-0144-306 BAG in 1 BOX (25000-144-30) / 6500 TABLET in 1 BAG
220 mg/125000-144-4325000-14425000-0144-4310 TABLET in 1 BOTTLE (25000-144-43)
220 mg/125000-144-9825000-14425000-0144-981 BAG in 1 BOX (25000-144-98) / 32165 TABLET in 1 BAG
220 mg/121130-748-2021130-74821130-0748-201 BOTTLE, PLASTIC in 1 BOX (21130-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/121130-748-4021130-74821130-0748-401 BOTTLE, PLASTIC in 1 BOX (21130-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/121130-748-8021130-74821130-0748-8080 CAPSULE, LIQUID FILLED in 1 BOTTLE (21130-748-80)
220 mg/130142-285-2230142-28530142-0285-221 BOTTLE, PLASTIC in 1 CARTON (30142-285-22) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/130142-285-7830142-28530142-0285-781 BOTTLE, PLASTIC in 1 CARTON (30142-285-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/137808-049-1537808-04937808-0049-151 BOTTLE, PLASTIC in 1 CARTON (37808-049-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/137808-049-1637808-04937808-0049-161 BOTTLE, PLASTIC in 1 CARTON (37808-049-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/137808-049-7837808-04937808-0049-781 BOTTLE, PLASTIC in 1 CARTON (37808-049-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/1, 25 mg/169842-328-0269842-32869842-0328-0220 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)
220 mg/137808-631-8237808-63137808-0631-82200 TABLET, FILM COATED in 1 BOTTLE (37808-631-82)
220 mg/136800-204-1136800-20436800-0204-111 BOTTLE, PLASTIC in 1 CARTON (36800-204-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/136800-204-1636800-20436800-0204-161 BOTTLE, PLASTIC in 1 CARTON (36800-204-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/136800-204-7836800-20436800-0204-781 BOTTLE, PLASTIC in 1 CARTON (36800-204-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/149035-382-2249035-38249035-0382-22120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-382-22)
220 mg/149035-382-7849035-38249035-0382-7880 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-382-78)
220 mg/141163-511-6241163-51141163-0511-621 BOTTLE in 1 CARTON (41163-511-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/141163-511-7141163-51141163-0511-711 BOTTLE in 1 CARTON (41163-511-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/141163-511-7541163-51141163-0511-751 BOTTLE in 1 CARTON (41163-511-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/162207-327-4162207-32762207-0327-4124 TABLET in 1 BOTTLE (62207-327-41)
220 mg/162207-327-4262207-32762207-0327-4250 TABLET in 1 BOTTLE (62207-327-42)
220 mg/162207-327-4362207-32762207-0327-43100 TABLET in 1 BOTTLE (62207-327-43)
220 mg/162207-327-4762207-32762207-0327-47500 TABLET in 1 BOTTLE (62207-327-47)
220 mg/162207-327-4962207-32762207-0327-491000 TABLET in 1 BOTTLE (62207-327-49)
220 mg/169842-811-6269842-81169842-0811-621 BOTTLE in 1 CARTON (69842-811-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/169842-811-7169842-81169842-0811-711 BOTTLE in 1 CARTON (69842-811-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/169842-811-7569842-81169842-0811-751 BOTTLE in 1 CARTON (69842-811-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/169842-811-9069842-81169842-0811-90500 TABLET, FILM COATED in 1 BOTTLE (69842-811-90)
220 mg/162207-328-4162207-32862207-0328-4124 TABLET in 1 BOTTLE (62207-328-41)
220 mg/162207-328-4262207-32862207-0328-4250 TABLET in 1 BOTTLE (62207-328-42)
220 mg/162207-328-4362207-32862207-0328-43100 TABLET in 1 BOTTLE (62207-328-43)
220 mg/162207-328-4762207-32862207-0328-47500 TABLET in 1 BOTTLE (62207-328-47)
220 mg/162207-328-4962207-32862207-0328-491000 TABLET in 1 BOTTLE (62207-328-49)
220 mg/149483-608-0049483-60849483-0608-006500 TABLET, FILM COATED in 1 BAG (49483-608-00)
220 mg/149483-608-0149483-60849483-0608-01100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01)
220 mg/149483-608-0549483-60849483-0608-0550 TABLET, FILM COATED in 1 BOTTLE (49483-608-05)
220 mg/149483-608-3149483-60849483-0608-31300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31)
25 mg/1, 220 mg/141163-593-7141163-59341163-0593-711 BOTTLE in 1 CARTON (41163-593-71) / 50 TABLET, FILM COATED in 1 BOTTLE
550 mg/150090-5238-350090-523850090-5238-0320 TABLET, FILM COATED in 1 BOTTLE (50090-5238-3)
550 mg/150090-5238-550090-523850090-5238-0530 TABLET, FILM COATED in 1 BOTTLE (50090-5238-5)
220 mg/149483-609-0049483-60949483-0609-006500 TABLET, FILM COATED in 1 BAG (49483-609-00)
220 mg/149483-609-0149483-60949483-0609-01100 TABLET, FILM COATED in 1 BOTTLE (49483-609-01)
220 mg/149483-609-0549483-60949483-0609-0550 TABLET, FILM COATED in 1 BOTTLE (49483-609-05)
220 mg/171335-1061-171335-106171335-1061-0120 TABLET, FILM COATED in 1 BOTTLE (71335-1061-1)
220 mg/171335-1061-271335-106171335-1061-0230 TABLET, FILM COATED in 1 BOTTLE (71335-1061-2)
220 mg/171335-1061-371335-106171335-1061-0340 TABLET, FILM COATED in 1 BOTTLE (71335-1061-3)
220 mg/171335-1061-471335-106171335-1061-0450 TABLET, FILM COATED in 1 BOTTLE (71335-1061-4)
220 mg/171335-1061-571335-106171335-1061-0560 TABLET, FILM COATED in 1 BOTTLE (71335-1061-5)
220 mg/171335-1061-671335-106171335-1061-0614 TABLET, FILM COATED in 1 BOTTLE (71335-1061-6)
220 mg/171335-1061-771335-106171335-1061-07100 TABLET, FILM COATED in 1 BOTTLE (71335-1061-7)
220 mg/171335-1061-871335-106171335-1061-0890 TABLET, FILM COATED in 1 BOTTLE (71335-1061-8)
220 mg/121130-180-7921130-18021130-0180-79400 TABLET, FILM COATED in 1 BOTTLE (21130-180-79)
220 mg/1, 25 mg/121130-814-0521130-81421130-0814-0550 TABLET in 1 BOTTLE (21130-814-05)
220 mg/162207-728-2462207-72862207-0728-2424 TABLET in 1 BOTTLE (62207-728-24)
220 mg/162207-728-4262207-72862207-0728-4250 TABLET in 1 BOTTLE (62207-728-42)
220 mg/162207-728-4362207-72862207-0728-43100 TABLET in 1 BOTTLE (62207-728-43)
220 mg/162207-728-4762207-72862207-0728-47500 TABLET in 1 BOTTLE (62207-728-47)
220 mg/162207-728-4962207-72862207-0728-491000 TABLET in 1 BOTTLE (62207-728-49)
220 mg/162207-729-2462207-72962207-0729-2424 TABLET in 1 BOTTLE (62207-729-24)
220 mg/162207-729-4262207-72962207-0729-4250 TABLET in 1 BOTTLE (62207-729-42)
220 mg/162207-729-4362207-72962207-0729-43100 TABLET in 1 BOTTLE (62207-729-43)
220 mg/162207-729-4762207-72962207-0729-47500 TABLET in 1 BOTTLE (62207-729-47)
220 mg/162207-729-4962207-72962207-0729-491000 TABLET in 1 BOTTLE (62207-729-49)
220 mg/137808-713-6237808-71337808-0713-621 BOTTLE in 1 CARTON (37808-713-62) / 24 TABLET, FILM COATED in 1 BOTTLE (37808-713-24)
Inner component37808-713-2437808-71337808-0713-24Inner component of kit (37808-713-62)
220 mg/137808-713-7137808-71337808-0713-711 BOTTLE in 1 CARTON (37808-713-71) / 50 TABLET, FILM COATED in 1 BOTTLE (37808-713-50)
Inner component37808-713-5037808-71337808-0713-50Inner component of kit (37808-713-71)
220 mg/137808-713-7537808-71337808-0713-751 BOTTLE in 1 CARTON (37808-713-75) / 90 TABLET, FILM COATED in 1 BOTTLE (37808-713-90)
Inner component37808-713-9037808-71337808-0713-90Inner component of kit (37808-713-75)
220 mg/137808-713-7937808-71337808-0713-79400 TABLET, FILM COATED in 1 BOTTLE (37808-713-79)
85 mg/1, 500 mg/144183-850-0944183-85044183-0850-099 TABLET in 1 BOTTLE (44183-850-09)
220 mg/151316-761-2051316-76151316-0761-20200 TABLET in 1 BOTTLE (51316-761-20)
220 mg/167091-138-5067091-13867091-0138-501 BOTTLE, PLASTIC in 1 CARTON (67091-138-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
220 mg/172476-748-2072476-74872476-0748-201 BOTTLE, PLASTIC in 1 BOX (72476-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/172476-748-8072476-74872476-0748-801 BOTTLE, PLASTIC in 1 BOX (72476-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
220 mg/155910-490-6255910-49055910-0490-621 BOTTLE in 1 CARTON (55910-490-62) / 24 TABLET, FILM COATED in 1 BOTTLE
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older: take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8 to 12 hour period do not exceed 3 caplets in a 24 hour period Children under 12 years: ask a doctor
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Search more NDCs & medical codes