Home NDC 25000-114 Ibuprofen
Product NDC 25000-114
11-digit product format 250000114
Labeler code 25000
Product ID 25000-114_1bdc2c02-575f-4b55-ad66-47108f628d18
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler MARKSANS PHARMA LIMITED
Application ANDA091239
Marketing category ANDA
Marketing start 2011-07-25
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 42 .
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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 e64feba35796…
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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 2 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 25000-114 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 8 Current NDC, Legacy NDC, 14 package rows 20211230_3c8df1e5-61bc-4e70-b6b9-8973986ad589.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 1 of 1 · 16 matching rows.
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 25000-114-02 25000011402 1 BOTTLE in 1 CARTON (25000-114-02) / 24 TABLET in 1 BOTTLE 1 bottle 2019-12-20 0000-00-00 No No Current 25000-114-03 25000011403 30 TABLET in 1 BOTTLE (25000-114-03) 30 tablet 2011-07-25 0000-00-00 No No Current 25000-114-14 25000011414 1000 TABLET in 1 BOTTLE (25000-114-14) 1000 tablet 2011-07-25 0000-00-00 No No Current 25000-114-20 25000011420 4 BAG in 1 BOX (25000-114-20) / 6500 TABLET in 1 BAG 4 bag 2011-07-25 0000-00-00 No No Current 25000-114-30 25000011430 6 BAG in 1 BOX (25000-114-30) / 6500 TABLET in 1 BAG 6 bag 2011-07-25 0000-00-00 No No Current 25000-114-70 25000011470 500 TABLET in 1 BOTTLE (25000-114-70) 500 tablet 2011-07-25 0000-00-00 No No Current 25000-114-71 25000011471 1000 TABLET in 1 BOTTLE (25000-114-71) 1000 tablet 2011-07-25 0000-00-00 No No Current 25000-114-93 25000011493 1 BAG in 1 BOX (25000-114-93) / 37470 TABLET in 1 BAG 1 bag 2011-07-25 0000-00-00 No No Current 25000-114-98 25000011498 1 BAG in 1 BOX (25000-114-98) / 34065 TABLET in 1 BAG 1 bag 2011-07-25 0000-00-00 No No Current