Home NDC 41250-993-20 Ibuprofen
Product NDC 41250-993
Requested package NDC 41250-993-20
11-digit product format 412500993
Labeler code 41250
Product ID 41250-993_1335bd3f-e04d-4ea7-b2bf-975c2aaa2b11
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA075139
Marketing category ANDA
Marketing start 1999-03-01
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 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 A075139-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 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 2 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Better Living Brands, LLC 45520969-7a2d-4469-ba25-7db160d50ccf 2026-07-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 027ded51-aa01-6619-3938-c8162a421cf3 2026-06-18 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 110, LLC. DBA Leader a41a0bc2-ef7a-44cd-a42e-aefab41323cc 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN ARMY AND AIR FORCE EXCHANGE SERVICE 01f8fe3a-8810-4b38-8860-d95e05d37709 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 107, LLC 260f5862-d65d-4c34-bf53-26ca30806a67 2026-05-19 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution, Inc. 3e3a5366-535d-45fb-81af-c7d98ac20b11 2026-05-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN CVS Pharmacy 00653b7c-7099-487e-9a01-e89781c21323 2026-04-29 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution Inc 36f7227d-f3cb-44b7-a4c1-27611cd15052 2026-04-24 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (package): 41250-993-20 ndc (product): 41250-993 ndc11 (package): 41250099320 Ibuprofen IBUPROFEN Rite Aid Corporation 72e11f2d-a348-4c12-9cd8-1e6f0f6f7399 2026-04-09 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye-Free IBUPROFEN Wal-Mart Stores Inc 23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6 2026-04-01 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN WALMART INC. 2b04d255-a1df-4698-9b5a-ad7a12205e1b 2026-03-25 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 pain relief ibuprofen IBUPROFEN Rite Aid Corporation 2bd1438e-27b1-81ff-f8e1-0f5b50b04581 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN H E B 88c7486b-f9a7-4856-a25a-7c06e1382f1a 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 82e907e6-86a9-5c7f-93bd-a6319d74100f 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 8ebe3e16-b7ae-d333-6671-5bc935e25900 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Major Pharmaceuticals 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 2025-12-17 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2025-12-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Family Dollar Services Inc 89ed9311-2185-4660-b219-9ea67b1a71ec 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Topco Associates, LLC bcf7d4c1-1f99-48df-8f74-9abeefa8d41d 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 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 41250-993-12 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 16 41250-993-12 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 16 41250-993-20 Ibuprofen 225 in 1 BOTTLE TABLET, FILM COATED 225 16 41250-993-91 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [MEIJER] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [MEIJER] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [MEIJER] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN TABLET, FILM COATED [MEIJER] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [MEIJER] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [MEIJER] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [MEIJER] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [MEIJER] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [MEIJER] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [MEIJER] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [MEIJER] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [MEIJER] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-993 IBUPROFEN TABLET, FILM COATED [MEIJER DISTRIBUTION INC] 14 Current NDC, Legacy NDC, 4 package rows 20250428_36f7227d-f3cb-44b7-a4c1-27611cd15052.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 41250-993-20 41250099320 225 TABLET, FILM COATED in 1 BOTTLE (41250-993-20) 1999-03-01 0000-00-00 No No Current