Home NDC 11822-0507-1 naproxen sodium
Product NDC 11822-0507
Requested package NDC 11822-0507-1
11-digit product format 118220507
Labeler code 11822
Product ID 11822-0507_54e97657-b9ef-48e4-9fd5-945a98d0b92a
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rite Aid Corporation
Application ANDA074661
Marketing category ANDA
Marketing start 2001-05-16
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0507 NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION] 7 Legacy NDC 20221112_af07cecf-e8f5-4f76-9df7-e634256f332f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11822-0507-1 11822050701 1 BOTTLE in 1 CARTON (11822-0507-1) > 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2001-06-25 0000-00-00 No No Current