Naproxen Sodium

Product NDC
71205-479
11-digit product format
712050479
Labeler code
71205
Product ID
71205-479_397db794-027c-4a89-993e-07c208b457a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200629
Marketing category
ANDA
Marketing start
2011-10-31
Substance
NAPROXEN SODIUM
Active strength
550 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
9TN87S3A3CNAPROXEN SODIUM26159-34-2NAPROXEN SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-479-157120504791515 TABLET, FILM COATED in 1 BOTTLE (71205-479-15) 2020-09-30NoNoHistorical
71205-479-307120504793030 TABLET, FILM COATED in 1 BOTTLE (71205-479-30) 2020-09-30NoNoHistorical
71205-479-607120504796060 TABLET, FILM COATED in 1 BOTTLE (71205-479-60) 2020-09-30NoNoHistorical
71205-479-907120504799090 TABLET, FILM COATED in 1 BOTTLE (71205-479-90) 2020-09-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naproxen SodiumProficient Rx LP2020-09-01HUMAN PRESCRIPTION DRUG LABEL1