Home NDC 61010-4410-2 Naproxen
Product NDC 61010-4410
Requested package NDC 61010-4410-2
11-digit product format 610104410
Labeler code 61010
Product ID 61010-4410_f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Safetec of America, Inc.
Application ANDA091353
Marketing category ANDA
Marketing start 2020-01-20
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 220 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-4410-0 Naproxen 1 in 1 POUCH TABLET 1 2 61010-4410-1 Naproxen 50 in 1 CARTON TABLET 50 2 61010-4410-2 Naproxen 100 in 1 CARTON TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-4410 NAPROXEN (NAPROXEN SODIUM) TABLET [SAFETEC OF AMERICA, INC.] 2 Legacy NDC, 3 package rows 20200125_287a381a-df7e-4e93-b097-1efde8a5f120.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61010-4410-2 61010441002 100 POUCH in 1 CARTON (61010-4410-2) > 1 TABLET in 1 POUCH (61010-4410-0) 100 pouch 2020-01-20 0000-00-00 No No Current