Home NDC 0904-7588-40 Ibuprofen
Product NDC 0904-7588
Requested package NDC 0904-7588-40
11-digit product format 009047588
Labeler code 0904
Product ID 0904-7588_4a1aa866-e39a-68e6-e063-6394a90a6432
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA071268
Marketing category ANDA
Marketing start 2025-11-03
Substance IBUPROFEN
Active strength 600 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071268-001 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 A071268-002 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 A071268-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-002 IBUPROFEN 400MG TABLET / ORAL AB 1986-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071268-003 IBUPROFEN 800MG TABLET / ORAL AB 1988-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071268-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-10-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 600 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197805 Internal RxNorm lookup 197806 Internal RxNorm lookup 197807 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 0904-7588-40 Ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 2 0904-7588-59 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Major Pharmaceuticals 42b6faf5-ef47-6a7a-e063-6394a90ac409 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 ndc (package): 0904-7588-40 ndc (product): 0904-7588 ndc11 (package): 00904758840 Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. f4d6372a-d560-0e14-e053-2a95a90a435a 2024-12-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268 Ibuprofen IBUPROFEN Florida Pharmaceutical Products, LLC c1733fdb-5eed-2094-e053-2995a90a6c8e 2024-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071268 application number: ANDA071268
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0904-7588-40 00904758840 500 TABLET, FILM COATED in 1 BOTTLE (0904-7588-40) 2025-11-03 No No Current