Naproxen

Product NDC
71335-1850
11-digit product format
713351850
Labeler code
71335
Product ID
71335-1850_e5a7112d-c916-4151-9307-cc7d801db648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Substance
NAPROXEN
Active strength
375 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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
57Y76R9ATQNAPROXEN22204-53-1NAPROXEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1850-17133518500120 TABLET in 1 BOTTLE (71335-1850-1) 20 tablet2021-12-21NoNoHistorical
71335-1850-27133518500230 TABLET in 1 BOTTLE (71335-1850-2) 30 tablet2021-12-21NoNoHistorical
71335-1850-37133518500340 TABLET in 1 BOTTLE (71335-1850-3) 40 tablet2021-12-21NoNoHistorical
71335-1850-471335185004120 TABLET in 1 BOTTLE (71335-1850-4) 120 tablet2021-12-21NoNoHistorical
71335-1850-57133518500560 TABLET in 1 BOTTLE (71335-1850-5) 60 tablet2021-12-21NoNoHistorical
71335-1850-67133518500690 TABLET in 1 BOTTLE (71335-1850-6) 90 tablet2021-12-21NoNoHistorical
71335-1850-77133518500714 TABLET in 1 BOTTLE (71335-1850-7) 14 tablet2021-12-21NoNoHistorical
71335-1850-87133518500815 TABLET in 1 BOTTLE (71335-1850-8) 15 tablet2021-12-21NoNoHistorical
71335-1850-97133518500921 TABLET in 1 BOTTLE (71335-1850-9) 21 tablet2021-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NaproxenBryant Ranch Prepack2026-05-15HUMAN PRESCRIPTION DRUG LABEL106