Prescription drug · ANDA

Naproxen NDC 76420-042

Naproxen 500 mg/1 · Tablet · Oral · Asclemed USA, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)76420-042Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0042Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
76420-042-01764200042011 TABLET in 1 BOTTLE, PLASTIC (76420-042-01)Marketed from Feb 5, 2020
76420-042-02764200042022 TABLET in 1 BOTTLE, PLASTIC (76420-042-02)Marketed from Feb 5, 2020
76420-042-1076420004210100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10)Marketed from Feb 5, 2020
76420-042-147642000421414 TABLET in 1 BOTTLE, PLASTIC (76420-042-14)Marketed from Feb 5, 2020
76420-042-307642000423030 TABLET in 1 BOTTLE, PLASTIC (76420-042-30)Marketed from Feb 5, 2020
76420-042-607642000426060 TABLET in 1 BOTTLE, PLASTIC (76420-042-60)Marketed from Feb 5, 2020
76420-042-907642000429090 TABLET in 1 BOTTLE, PLASTIC (76420-042-90)Marketed from Feb 5, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Naproxen
Generic name (nonproprietary)
naproxen
Active ingredients
Naproxen — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091416
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 76420-042_ead160e6-aba4-ca0a-e053-2a95a90ab964SPL ID ead160e6-aba4-ca0a-e053-2a95a90ab964SPL set ID a4fcb411-c918-459b-adc6-06dfa8ed8a50RxCUI 198014UNII 57Y76R9ATQ

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420004201 followed by a unit qualifier and the quantity

Package 76420-0042-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED: FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS NAPROXEN TABLETS ARE ALSO INDICATED: FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS FOR RELIEF OF…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-042

What is NDC 76420-042?
76420-042 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen.
What is the active ingredient?
Naproxen.
Who is the labeler?
Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naproxen?
185 other product NDCs are listed under this name. See all Naproxen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NaproxenNaproxen 500 mg/1TabletOralREMEDYREPACK INC.70518-475070518-4750-00
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-078467046-0784-03
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-049967046-0499-03
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-050067046-0500-03
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-050167046-0501-03
NaproxenNaproxen 375 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21111534-0211-01
NaproxenNaproxen 500 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21211534-0212-01
NaproxenNaproxen 250 mg/1TabletOralREMEDYREPACK INC.70518-451470518-4514-00
NaproxenNaproxen 500 mg/1TabletOralMedcore LLC82461-71182461-0711-60
NaproxenNaproxen 125 mg/5mLSuspensionOralAurobindo Pharma Limited59651-52859651-0528-47

All 186 Naproxen NDCs

Other NDCs under ANDA 091416

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091416
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4381
NaproxenNaproxen 375 mg/1TabletOralTIME CAP LABORATORIES49483-617
NaproxenNaproxen 500 mg/1TabletOralTIME CAP LABORATORIES49483-618
NaproxenNaproxen 250 mg/1TabletOralTIME CAP LABORATORIES49483-619
NaproxenNaproxen 500 mg/1TabletOralQPharma Inc42708-140
NaproxenNaproxen 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4510
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack71335-0973
NaproxenNaproxen 500 mg/1TabletOralDIRECT RX72189-136
NaproxenNaproxen 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-920
NaproxenNaproxen 500 mg/1TabletOralNorthwind Health Company, LLC51655-621
NaproxenNaproxen 375 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0048
NaproxenNaproxen 375 mg/1TabletOralMARKSANS PHARMA LIMITED25000-139
NaproxenNaproxen 250 mg/1TabletOralMARKSANS PHARMA LIMITED25000-138
NaproxenNaproxen 500 mg/1TabletOralMARKSANS PHARMA LIMITED25000-140
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4006
NaproxenNaproxen 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-436
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack71335-0255

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