NDC codes

FDA NDC Directory
Product NDC (as listed)76420-264Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0264Add 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
76420-264-0176420026401764200264011 TABLET in 1 BOTTLE (76420-264-01)Marketed from Aug 17, 2022
76420-264-0276420026402764200264022 TABLET in 1 BOTTLE (76420-264-02)Marketed from Aug 17, 2022
76420-264-057642002640576420026405500 TABLET in 1 BOTTLE (76420-264-05)Marketed from Aug 17, 2022
76420-264-0776420026407764200264077 TABLET in 1 BOTTLE (76420-264-07)Marketed from Mar 31, 2023
76420-264-107642002641076420026410100 TABLET in 1 BOTTLE (76420-264-10)Marketed from Aug 17, 2022
76420-264-127642002641276420026412120 TABLET in 1 BOTTLE (76420-264-12)Marketed from Apr 11, 2025
76420-264-14764200264147642002641414 TABLET in 1 BOTTLE (76420-264-14)Marketed from Aug 17, 2022
76420-264-20764200264207642002642020 TABLET in 1 BOTTLE (76420-264-20)Marketed from Sep 2, 2023
76420-264-30764200264307642002643030 TABLET in 1 BOTTLE (76420-264-30)Marketed from Aug 17, 2022
76420-264-60764200264607642002646060 TABLET in 1 BOTTLE (76420-264-60)Marketed from Aug 17, 2022
76420-264-90764200264907642002649090 TABLET in 1 BOTTLE (76420-264-90)Marketed from Aug 17, 2022

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 212517
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 76420-264_327a22dc-b87a-2758-e063-6394a90ae257SPL ID 327a22dc-b87a-2758-e063-6394a90ae257SPL set ID 1e406e47-408a-48cc-921e-52882a11581cRxCUI 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

N476420026401 followed by a unit qualifier and the quantity

Package 76420-0264-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Naproxen Tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-264

What is NDC 76420-264?
76420-264 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 11 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?
189 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/1TabletOralUnit Dose Solutions, Inc.87441-09287441-0092-01
NaproxenNaproxen 500 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-19060760-0190-60
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

All 190 Naproxen NDCs

Other NDCs under ANDA 212517

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

FDA NDC Directory listings under ANDA 212517
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 375 mg/1TabletOralMedsource Pharmaceuticals45865-238
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5645
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5646
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-5649
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-7676
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-8102
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-8103
NaproxenNaproxen 250 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-434
NaproxenNaproxen 375 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-435
NaproxenNaproxen 500 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-436
NaproxenNaproxen 375 mg/1TabletOralNorthwind Health Company, LLC51655-657
NaproxenNaproxen 500 mg/1TabletOralNorthwind Health Company, LLC51655-743
NaproxenNaproxen 500 mg/1TabletOralQuality Care Products, LLC55700-888
NaproxenNaproxen 500 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-564
NaproxenNaproxen 375 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-644
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack63629-8511
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack63629-8512
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack63629-8513
NaproxenNaproxen 500 mg/1TabletOralBryant Ranch Prepack63629-8514
NaproxenNaproxen 500 mg/1TabletOralBryant Ranch Prepack63629-8515

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