NAPROXEN SODIUM

Product NDC
41226-609
11-digit product format
412260609
Labeler code
41226
Product ID
41226-609_c3d6166b-be1b-328a-e053-2a95a90af589
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kroger Company
Application
ANDA090545
Marketing category
ANDA
Marketing start
2021-06-12
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
41226-609-05412260609051 BOTTLE in 1 CARTON (41226-609-05) / 50 TABLET, COATED in 1 BOTTLE1 bottle2021-06-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
609R Kroger 41226 609 Naproxen Sodium tablets USP,220mg 50ctKroger Company | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED2021-06-03HUMAN OTC DRUG LABEL2