Home NDC 0363-0490 Pain Relief
Product NDC 0363-0490
11-digit product format 003630490
Labeler code 0363
Product ID 0363-0490_d13ca2bb-203a-4ec8-a43a-5354ee567b28
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 1997-01-14
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 220 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0490-62 00363049062 1 BOTTLE in 1 CARTON (0363-0490-62) > 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-01-14 0000-00-00 No No Current 0363-0490-71 00363049071 1 BOTTLE in 1 CARTON (0363-0490-71) > 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-01-14 0000-00-00 No No Current 0363-0490-76 00363049076 1 BOTTLE in 1 CARTON (0363-0490-76) > 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2002-06-20 0000-00-00 No No Current 0363-0490-78 00363049078 1 BOTTLE in 1 CARTON (0363-0490-78) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-01-14 0000-00-00 No No Current 0363-0490-82 00363049082 1 BOTTLE in 1 CARTON (0363-0490-82) > 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2012-10-06 0000-00-00 No No Current