Home NDC 0363-9600 IBUPROFEN
Product NDC 0363-9600
11-digit product format 003639600
Labeler code 0363
Product ID 0363-9600_13e957be-9a42-aa4e-e063-6394a90a2ae8
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET
Route ORAL
Labeler WALGREENS
Application ANDA091239
Marketing category ANDA
Marketing start 2018-12-11
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 A091239-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2011-02-01
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 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 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 1 · 16 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base IBUPROFEN
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 0363-9600-01 IBUPROFEN 100 in 1 BOTTLE, PLASTIC TABLET 100 6 0363-9600-05 IBUPROFEN 50 in 1 BOTTLE, PLASTIC TABLET 50 6 0363-9600-31 IBUPROFEN 300 in 1 BOTTLE, GLASS TABLET 300 6 0363-9600-42 IBUPROFEN 24 in 1 BOTTLE, PLASTIC TABLET 24 6 0363-9600-50 IBUPROFEN 500 in 1 BOTTLE, PLASTIC TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9600 IBUPROFEN TABLET [WALGREENS] 6 Current NDC, Legacy NDC, 5 package rows 20240320_746f79aa-3036-1b9b-e053-2a91aa0a1db6.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 0363-9600-01 00363960001 100 TABLET in 1 BOTTLE, PLASTIC (0363-9600-01) 100 tablet 2018-12-11 0000-00-00 No No Current 0363-9600-05 00363960005 50 TABLET in 1 BOTTLE, PLASTIC (0363-9600-05) 50 tablet 2018-12-11 0000-00-00 No No Current 0363-9600-31 00363960031 300 TABLET in 1 BOTTLE, GLASS (0363-9600-31) 300 tablet 2018-12-11 0000-00-00 No No Current 0363-9600-42 00363960042 24 TABLET in 1 BOTTLE, PLASTIC (0363-9600-42) 24 tablet 2018-12-11 0000-00-00 No No Current 0363-9600-50 00363960050 500 TABLET in 1 BOTTLE, PLASTIC (0363-9600-50) 500 tablet 2018-12-11 0000-00-00 No No Current