Over-the-counter drug · ANDA

Pain Relief (Naproxen sodium) NDC 82501-1576

Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Gobrands, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)82501-1576Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82501-1576Add 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
82501-1576-18250115760182501157601100 TABLET, FILM COATED in 1 BOTTLE (82501-1576-1)Marketed from May 30, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Pain Relief
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Gobrands, IncNDC labeler code 82501
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091353
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 82501-1576_29ba15a4-8de5-e97f-e063-6394a90a6c9aSPL ID 29ba15a4-8de5-e97f-e063-6394a90a6c9aSPL set ID ae4bfa8c-ae41-4fcd-b584-872cc4d37683RxCUI 849574UNII 9TN87S3A3C

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

N482501157601 followed by a unit qualifier and the quantity

Package 82501-1576-01. 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)

Uses temporarily relieves minor aches and pains due to: backache n headache n menstrual cramps minor pain of arthritis n muscular aches the common cold n toothache temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82501-1576

What is NDC 82501-1576?
82501-1576 is the product NDC for Pain Relief (naproxen sodium), Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by Gobrands, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief (Naproxen Sodium).
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Gobrands, Inc, NDC labeler code 82501. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pain Relief?
62 other product NDCs are listed under this name. See all Pain Relief 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 Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain ReliefacetaminophenAcetaminophen 325 mg/1TabletOralShield Pharmaceuticals Corp.83059-0160—
Pain Reliefmenthol sprayMenthol 76.6 mg/mLSprayTopicalOwell Naturals Brand, LLC83570-00383570-0003-02
Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix albaArnica montana whole 6 [hp_X]/1 + 6 more ingredientsTabletOralNaturalCare70163-002270163-0022-01
pain reliefacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralHyVee Inc42507-81342507-0813-78
Pain ReliefmentholMenthol 10.5 g/100mLSprayTopicalTrifecta Pharmaceuticals USA, LLC.69396-17569396-0175-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralHYVEE INC42507-10342507-0103-04
Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHYVEE INC42507-30342507-0303-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-40442507-0404-09
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-59242507-0592-03
Pain RelieflidocaineLidocaine .04 g/gPatchTopicalShanghai Chuangshi Medical Technology (Group) Co., Ltd.73557-18973557-0189-30

All 63 Pain Relief NDCs

Other NDCs under ANDA 091353

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

FDA NDC Directory listings under ANDA 091353
ProductStrengthForm · routeLabelerProduct NDC
All Day Pain Reliefnaproxen sodium tablets, 220 mgNaproxen sodium 220 mg/1TabletOralHealthLife of USA LLC69517-109
Dr Simi All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralFarmacias De Similares TX LLC85786-104
NaproxenNaproxen sodium 220 mg/1TabletOralSafeway, Inc21130-062
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralTARGET CORPORATION11673-764
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralSafeway, Inc21130-061
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralCVS51316-761
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralCVS51316-762
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-327
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-328
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-728
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-729
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralGranules India Ltd62207-761
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralGranules India Ltd62207-762
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coated, Extended releaseOralSPIRIT PHARMACEUTICALS,LLC68210-4096
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules USA, Inc.69848-010
Proxen Np 660naproxen sodiumNaproxen sodium 220 mg/1TabletOralOPMX LLC69729-123
Rapidol Naproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralPharmadel LLC55758-048

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