Naproxen Sodium

Product NDC
43598-071
11-digit product format
435980071
Labeler code
43598
Product ID
43598-071_c94f5885-67ab-4e95-df53-a58f119c504b
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA075168
Marketing category
ANDA
Marketing start
2021-12-10
Substance
NAPROXEN SODIUM
Active strength
220 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-071-01435980071011 BOTTLE in 1 CARTON (43598-071-01) / 100 TABLET, COATED in 1 BOTTLE1 bottle2021-12-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NAPROXEN SODIUM TABLETS USP, 220 mgDr.Reddy's Laboratories Inc2025-06-03HUMAN OTC DRUG LABEL6