Over-the-counter drug · ANDA

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever NDC 53746-191

naproxen sodium · Naproxen sodium 220 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)53746-191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53746-0191Add 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
53746-191-0553746019105500 TABLET in 1 BOTTLE (53746-191-05)Marketed from Nov 25, 2009
53746-191-08537460191088 TABLET in 1 VIAL (53746-191-08)Marketed from Nov 25, 2009
53746-191-245374601912424 TABLET in 1 BOTTLE (53746-191-24)Marketed from Nov 25, 2009

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 Sodium (NSAID) Fever Reducer/ Pain RelieverSuffix: Fever Reducer/ Pain Reliever
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079096
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 53746-191_9cc39ab5-450a-4e0b-948d-fdebd66c0f6fSPL ID 9cc39ab5-450a-4e0b-948d-fdebd66c0f6fSPL set ID 0bb41b8c-6031-4e96-95e1-31adab811837RxCUI 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

N453746019105 followed by a unit qualifier and the quantity

Package 53746-0191-05. 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)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079096

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

FDA NDC Directory listings under ANDA 079096
ProductStrengthForm · routeLabelerProduct NDC
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWinCo Foods, LLC67091-140
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWinCo Foods, LLC67091-138
Belmora Flanaxnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-037
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-844
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralFSA STORE INC.81522-045
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHarris Teeter72036-144
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHarris Teeter72036-145
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-144
Medique Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-237
CAREALL Naproxennaproxen sodiumNaproxen sodium 220 mg/1TabletOralNew World Imports, Inc.51824-072
Naproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-144
Naproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-145
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-245
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-145
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-465
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-466
Medique Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2388
CAREALL Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1TabletOralNew World Imports, Inc.51824-109
Naproxen Sodium (NSAID) Fever Reducer/ Pain Relievernaproxen sodiumNaproxen sodium 220 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-192
Medique Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralSportpharm LLC85766-121

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