Over-the-counter drug · ANDA

Naproxen (Naproxen sodium) NDC 53943-145

Naproxen sodium 220 mg/1 · Tablet, Coated · Oral · DISCOUNT DRUG MART

NDC codes

FDA NDC Directory
Product NDC (as listed)53943-145Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0145Add 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
53943-145-0253943014502539430145021 BOTTLE, PLASTIC in 1 CARTON (53943-145-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 28, 2014
53943-145-0353943014503539430145031 BOTTLE, PLASTIC in 1 CARTON (53943-145-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 28, 2014

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 sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
DISCOUNT DRUG MARTNDC labeler code 53943
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 53943-145_35316cb3-d33d-81c6-e063-6294a90a8380SPL ID 35316cb3-d33d-81c6-e063-6294a90a8380SPL set ID a0c67043-1e78-4eac-86e6-497b4364651aRxCUI 849574UNII 9TN87S3A3CUPC 0093351017209

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

N453943014502 followed by a unit qualifier and the quantity

Package 53943-0145-02. 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: minor pain of arthritis muscular aches backache 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)

About NDC 53943-145

What is NDC 53943-145?
53943-145 is the product NDC for Naproxen (naproxen sodium), Naproxen sodium 220 mg/1 tablet, coated, listed with the FDA by DISCOUNT DRUG MART. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen (Naproxen sodium).
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
DISCOUNT DRUG MART, NDC labeler code 53943. 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 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, CoatedOralAAA Pharmaceutical, Inc.57344-145
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-244
Medique Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-237
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1TabletOralH E B37808-068
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWinCo Foods, LLC67091-138
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWinCo Foods, LLC67091-140
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-108
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-109
Medique Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2388
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-245
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-245
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralFSA STORE INC.81522-045
CAREALL Naproxennaproxen sodiumNaproxen sodium 220 mg/1TabletOralNew World Imports, Inc.51824-072
Medique at Home Mediproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-737
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-465
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralChain Drug Marketing Association63868-466
Naproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-144
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-145
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-444
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-445

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