NDC 63629-3726Prescription (Rx only)FDA ANDA · ANDA090066

Diclofenac Sodium

Active substance: Diclofenac Sodium

FDA labeler: Bryant Ranch Prepack

50 formulations • 95 package configurations
All 145 registered NDCs — click to copy
In one line

Diclofenac Sodium (Diclofenac Sodium) NDC 63629-3726 converts to 63629-3726-01 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: 63629-3726
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
63629-3726-01
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 Diclofenac Sodium, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
20 mg/g21922-033-1621922-03321922-0033-161 BOTTLE, PUMP in 1 CARTON (21922-033-16) / 112 g in 1 BOTTLE, PUMP
25 mg/163629-3726-163629-372663629-3726-0160 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-3726-1)
30 mg/g80425-0338-180425-033880425-0338-011 TUBE in 1 CARTON (80425-0338-1) / 100 g in 1 TUBE
30 mg/g85534-0089-085534-008985534-0089-001 TUBE in 1 CARTON (85534-0089-0) / 100 g in 1 TUBE
10 mg/g85766-240-0185766-24085766-0240-011 TUBE in 1 CARTON (85766-240-01) / 100 g in 1 TUBE
75 mg/1, 200 ug/175834-265-6075834-26575834-0265-6060 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)
16.05 mg/mL76420-012-3076420-01276420-0012-30150 mL in 1 BOTTLE (76420-012-30)
20 mg/g80425-0550-180425-055080425-0550-011 BOTTLE in 1 CARTON (80425-0550-1) / 112 g in 1 BOTTLE
75 mg/172162-1734-072162-173472162-1734-001000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-0)
75 mg/172162-1734-172162-173472162-1734-01100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-1)
75 mg/172162-1734-372162-173472162-1734-0330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-3)
75 mg/172162-1734-472162-173472162-1734-0420 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-4)
75 mg/172162-1734-572162-173472162-1734-05500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-5)
75 mg/172162-1734-672162-173472162-1734-0660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-6)
75 mg/172162-1734-772162-173472162-1734-0714 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-7)
75 mg/172162-1734-872162-173472162-1734-0815 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-8)
75 mg/172162-1734-972162-173472162-1734-0990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-9)
50 mg/1, 200 ug/165162-436-0365162-43665162-0436-0330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-03)
50 mg/1, 200 ug/165162-436-0665162-43665162-0436-0660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-06)
50 mg/1, 200 ug/165162-436-0965162-43665162-0436-0990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-09)
50 mg/1, 200 ug/165162-436-1065162-43665162-0436-10100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-10)
75 mg/1, 200 ug/165162-438-0365162-43865162-0438-0330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03)
75 mg/1, 200 ug/165162-438-0665162-43865162-0438-0660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06)
75 mg/1, 200 ug/165162-438-1065162-43865162-0438-10100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)
30 mg/g72189-040-0172189-04072189-0040-011 g in 1 TUBE (72189-040-01)
50 mg/1, 200 ug/175834-264-6075834-26475834-0264-6060 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-60)
50 mg/1, 200 ug/175834-264-9075834-26475834-0264-9090 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-90)
75 mg/150090-6924-050090-692450090-6924-0090 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6924-0)
50 mg/151407-537-0151407-53751407-0537-01100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-01)
50 mg/151407-537-1051407-53751407-0537-101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-10)
50 mg/151407-537-1851407-53751407-0537-18180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-18)
75 mg/171335-0357-071335-035771335-0357-0040 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-0)
75 mg/171335-0357-171335-035771335-0357-0128 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-1)
75 mg/171335-0357-271335-035771335-0357-0260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-2)
75 mg/171335-0357-371335-035771335-0357-0320 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-3)
75 mg/171335-0357-471335-035771335-0357-0430 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-4)
75 mg/171335-0357-571335-035771335-0357-05120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-5)
75 mg/171335-0357-671335-035771335-0357-0690 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-6)
75 mg/171335-0357-771335-035771335-0357-07100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-7)
75 mg/171335-0357-871335-035771335-0357-0815 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-8)
75 mg/171335-0357-971335-035771335-0357-0914 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-9)
50 mg/182868-101-3082868-10182868-0101-3030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-101-30)
50 mg/182868-101-9082868-10182868-0101-9090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-101-90)
20 mg/g83008-019-1283008-01983008-0019-121 BOTTLE, PUMP in 1 CARTON (83008-019-12) / 112 g in 1 BOTTLE, PUMP
30 mg/g68788-8456-168788-845668788-8456-011 TUBE in 1 CARTON (68788-8456-1) / 100 g in 1 TUBE
25 mg/151407-536-0151407-53651407-0536-01100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-536-01)
30 mg/g82804-250-0082804-25082804-0250-001 TUBE in 1 CARTON (82804-250-00) / 100 g in 1 TUBE
30 mg/g72189-379-0172189-37972189-0379-011 g in 1 TUBE (72189-379-01)
75 mg/151407-538-0151407-53851407-0538-01100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-01)
75 mg/151407-538-1051407-53851407-0538-101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-10)
75 mg/151407-538-1851407-53851407-0538-18180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-18)
10 mg/g83008-037-0083008-03783008-0037-001 TUBE in 1 CARTON (83008-037-00) / 100 g in 1 TUBE
10 mg/g68788-4335-168788-433568788-4335-011 TUBE in 1 CARTON (68788-4335-1) / 100 g in 1 TUBE
100 mg/142799-953-0142799-95342799-0953-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01)
10 mg/g63941-812-5363941-81263941-0812-531 TUBE in 1 CARTON (63941-812-53) / 100 g in 1 TUBE
10 mg/g63941-812-7663941-81263941-0812-761 TUBE in 1 CARTON (63941-812-76) / 50 g in 1 TUBE
30 mg/g76420-025-0176420-02576420-0025-01100 g in 1 TUBE (76420-025-01)
75 mg/180425-0564-180425-056480425-0564-0130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-1)
75 mg/180425-0564-280425-056480425-0564-0260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-2)
75 mg/180425-0564-380425-056480425-0564-0390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-3)
30 mg/g70518-3779-070518-377970518-3779-001 TUBE in 1 CARTON (70518-3779-0) / 100 g in 1 TUBE
50 mg/180425-0569-180425-056980425-0569-0160 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-1)
50 mg/180425-0569-280425-056980425-0569-0290 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-2)
16.05 mg/mL72189-075-0572189-07572189-0075-05150 mL in 1 BOTTLE (72189-075-05)
50 mg/1, 200 ug/10591-0397-190591-039700591-0397-1990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)
50 mg/1, 200 ug/10591-0397-600591-039700591-0397-6060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)
75 mg/182868-114-3082868-11482868-0114-3030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-114-30)
10 mg/g30142-277-1030142-27730142-0277-101 TUBE in 1 CARTON (30142-277-10) / 100 g in 1 TUBE
10 mg/g30142-277-1530142-27730142-0277-151 TUBE in 1 CARTON (30142-277-15) / 150 g in 1 TUBE
10 mg/g30142-277-5030142-27730142-0277-501 TUBE in 1 CARTON (30142-277-50) / 50 g in 1 TUBE
50 mg/160290-083-0160290-08360290-0083-0160 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-01)
50 mg/160290-083-0260290-08360290-0083-02100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-02)
50 mg/160290-083-0360290-08360290-0083-03500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-03)
50 mg/160290-083-0460290-08360290-0083-041000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-04)
75 mg/170518-0627-170518-062770518-0627-0190 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-1)
75 mg/170518-0627-270518-062770518-0627-0260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-2)
75 mg/150090-7818-050090-781850090-7818-0090 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7818-0)
75 mg/163187-222-1563187-22263187-0222-1515 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-15)
75 mg/163187-222-3063187-22263187-0222-3030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-30)
75 mg/163187-222-6063187-22263187-0222-6060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-60)
75 mg/163187-222-9063187-22263187-0222-9090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-90)
25 mg/160290-082-0160290-08260290-0082-01100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-082-01)
16.05 mg/mL71205-640-1571205-64071205-0640-151 BOTTLE in 1 CARTON (71205-640-15) / 150 mL in 1 BOTTLE
50 mg/171610-068-8071610-06871610-0068-80180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80)
75 mg/1, 200 ug/10591-0398-600591-039800591-0398-6060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-60)
75 mg/160290-084-0160290-08460290-0084-0160 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-01)
75 mg/160290-084-0260290-08460290-0084-02100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-02)
75 mg/160290-084-0360290-08460290-0084-03500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-03)
75 mg/160290-084-0460290-08460290-0084-041000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-04)
75 mg/180425-0055-180425-005580425-0055-0160 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0055-1)
10 mg/g50090-4020-050090-402050090-4020-001 TUBE in 1 CARTON (50090-4020-0) / 100 g in 1 TUBE
10 mg/g50090-4030-050090-403050090-4030-001 TUBE in 1 CARTON (50090-4030-0) / 100 g in 1 TUBE
75 mg/172789-578-2072789-57872789-0578-2020 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-20)
75 mg/172789-578-3072789-57872789-0578-3030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-30)
20 mg/g68180-537-0168180-53768180-0537-011 BOTTLE, PUMP in 1 CARTON (68180-537-01) / 112 g in 1 BOTTLE, PUMP
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 for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Directions Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.
Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but 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 apply more or for longer 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 or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before us if you have problems or serious side effects from taking pain relievers or fever reducers 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, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. 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 avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if pain gets worse or lasts more than 21 days redness or swelling is present in the painful area fever occurs skin irritation occurs any new symptoms appear. These could be signs of a serious condition. you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product 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. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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