Home NDC 76282-712 Ibuprofen
Product NDC 76282-712
11-digit product format 762820712
Labeler code 76282
Product ID 76282-712_bc309c22-f359-42b1-86db-3970a5d53bc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler EXELAN PHARMACEUTICALS, INC.
Application ANDA091625
Marketing category ANDA
Marketing start 2022-03-10
Substance IBUPROFEN
Active strength 400 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 43 .
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 A091625-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 A091625-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 A091625-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15
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 · 129 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 2026-09-14 22:38:34 2026-08 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-002 IBUPROFEN 600MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091625-003 IBUPROFEN 800MG TABLET / ORAL AB 2015-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091625-001 IBUPROFEN 400MG TABLET / ORAL AB 2015-09-15 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 400 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 76282-712-10 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 3 76282-712-45 Ibuprofen 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 76282-712-46 Ibuprofen 100 in 1 CARTON TABLET, FILM COATED 100 3 76282-712-50 Ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 3 76282-712-55 Ibuprofen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-712 IBUPROFEN TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 5 package rows 20240427_362f934a-4382-43bc-bedd-65081286f1c9.zip
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 3 of 3 · 41 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 4a86a190-da5d-4b7a-a05f-e3e7ccbfa603 2019-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091625 application number: ANDA091625
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 76282-712-10 76282071210 100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10) 2022-03-10 0000-00-00 No No Current 76282-712-45 76282071245 10 in 1 BLISTER PACK Historical 76282-712-46 76282071246 100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45) 100 blister pack 2022-03-10 No No Current 76282-712-50 76282071250 500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50) 2022-03-10 0000-00-00 No No Current 76282-712-55 76282071255 1000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55) 2022-03-10 0000-00-00 No No Current 76282-712-64 76282071264 10000 TABLET, FILM COATED in 1 POUCH (76282-712-64) 2022-03-23 0000-00-00 No No Current