Home NDC 0363-1517-78 ibuprofen 200
Product NDC 0363-1517
Requested package NDC 0363-1517-78
11-digit product format 003631517
Labeler code 0363
Product ID 0363-1517_d7333eba-e5a2-4e80-aa6b-aa0102ebe6d4
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application ANDA077349
Marketing category ANDA
Marketing start 2021-10-20
Substance IBUPROFEN
Active strength 200 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 2026-12-31
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 A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
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 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 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 · 21 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ibuprofen 200
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 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 0363-1517-78 ibuprofen 200 100 in 1 BOTTLE TABLET, FILM COATED 100 4 0363-1517-78 ibuprofen 200 1 in 1 CARTON TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1517 IBUPROFEN 200 (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20230425_49a3d51d-55d1-4b80-ab7b-35c27a937cb9.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 0363-1517-78 00363151778 1 BOTTLE in 1 CARTON (0363-1517-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-10-20 0000-00-00 No No Current