Naproxen

Product NDC
50090-7676
11-digit product format
500907676
Labeler code
50090
Product ID
50090-7676_03f0493b-2440-4e4f-a5ac-a079a564f408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
57Y76R9ATQNAPROXEN22204-53-1NAPROXEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7676-05009076760090 TABLET in 1 BOTTLE (50090-7676-0) 90 tablet2025-10-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NaproxenA-S Medication Solutions2025-11-02HUMAN PRESCRIPTION DRUG LABEL1