Home NDC 12634-518 Ibuprofen
Product NDC 12634-518
11-digit product format 126340518
Labeler code 12634
Product ID 12634-518_2757f53a-602c-4678-80f5-61c3d9dfd4a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Apotheca, Inc
Application ANDA091239
Marketing category ANDA
Marketing start 2014-02-14
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 200 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-518-01 Ibuprofen 100 in 1 BOTTLE TABLET 100 1 12634-518-10 Ibuprofen 1000 in 1 BOTTLE TABLET 1000 1 12634-518-74 Ibuprofen 24 in 1 BOTTLE TABLET 24 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-518 IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] 1 Legacy NDC, 3 package rows 20140405_3fd625e4-0d06-4efb-abd1-42281e7a6af0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 12634-518-01 12634051801 100 in 1 BOTTLE Historical 12634-518-10 12634051810 1000 in 1 BOTTLE Historical 12634-518-74 12634051874 24 in 1 BOTTLE Historical