Naproxen Sodium

Product NDC
62207-327
11-digit product format
622070327
Labeler code
62207
Product ID
62207-327_f4026a0a-c9cd-3850-e053-2995a90a459c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA091353
Marketing category
ANDA
Marketing start
2021-07-16
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
62207-327-416220703274124 TABLET in 1 BOTTLE (62207-327-41) 24 tablet2021-07-16NoNoHistorical
62207-327-426220703274250 TABLET in 1 BOTTLE (62207-327-42) 50 tablet2021-07-16NoNoHistorical
62207-327-4362207032743100 TABLET in 1 BOTTLE (62207-327-43) 100 tablet2021-07-16NoNoHistorical
62207-327-4762207032747500 TABLET in 1 BOTTLE (62207-327-47) 500 tablet2021-07-16NoNoHistorical
62207-327-49622070327491000 TABLET in 1 BOTTLE (62207-327-49) 1000 tablet2021-07-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naproxen Sodium Tablets, USP 220 mgGranules India Ltd2023-02-06HUMAN OTC DRUG LABEL9