Home NDC 85828-394 Naproxen Sodium 220mg
Product NDC 85828-394
11-digit product format 858280394
Labeler code 85828
Product ID 85828-394_2f95e668-908b-43f7-b193-93259eaef66f
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium 220mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Grocery Outlet
Application ANDA090545
Marketing category ANDA
Marketing start 2026-03-18
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 2027-12-31
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 A090545-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16
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 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 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 2 · 22 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Sodium 220mg
Listing expiration 2027-12-31 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 85828-394-92 Naproxen Sodium 220mg 1 in 1 CARTON TABLET, FILM COATED 1 1 85828-394-92 Naproxen Sodium 220mg 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85828-394-92 85828039492 1 BOTTLE in 1 CARTON (85828-394-92) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-03-18 No No Current