Home NDC 0363-0140-82 pain relief
Product NDC 0363-0140
Requested package NDC 0363-0140-82
11-digit product format 003630140
Labeler code 0363
Product ID 0363-0140_fc3ff125-b7a0-4cd2-aed8-e0dfb6ca5f0b
Type HUMAN OTC DRUG
Nonproprietary name Naproxen sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application ANDA074661
Marketing category ANDA
Marketing start 2011-10-22
Marketing end 0000-00-00
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 2023-12-31
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 A074661-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13
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 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 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 3 · 56 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0140 PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY] 9 Legacy NDC 20250327_e8f3d7e8-cd29-4536-86b7-44c3d5f08ba6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0363-0140-82 00363014082 200 TABLET, FILM COATED in 1 BOTTLE (0363-0140-82) 2011-10-22 0000-00-00 No No Current