Home NDC 62207-761-24 Naproxen Sodium
Product NDC 62207-761
Requested package NDC 62207-761-24
11-digit product format 622070761
Labeler code 62207
Product ID 62207-761_f4026a0a-c9cd-3850-e053-2995a90a459c
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules India Ltd
Application ANDA091353
Marketing category ANDA
Marketing start 2011-09-30
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091353-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 14 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 220 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849574 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62207-761-42 Naproxen Sodium 50 in 1 BOTTLE TABLET, FILM COATED 50 9 62207-761-43 Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 9 62207-761-47 Naproxen Sodium 500 in 1 BOTTLE TABLET, FILM COATED 500 9 62207-761-49 Naproxen Sodium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-761 NAPROXEN SODIUM TABLET NAPROXEN SODIUM TABLET, FILM COATED [GRANULES INDIA LTD] 9 Current NDC, Legacy NDC, 4 package rows 20230207_95ba1722-60ed-4a83-9f26-50c4de8cf180.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 62207-761-24 62207076124 48000 TABLET, FILM COATED in 1 BOX (62207-761-24) 12-MAR-14 Current