Home NDC 25000-117 Ibuprofen
Product NDC 25000-117
11-digit product format 250000117
Labeler code 25000
Product ID 25000-117_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 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.
Product history page 1 of 2 · 41 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091239-001 IBUPROFEN 200MG TABLET / ORAL 2011-02-01 cb3db0bc1861…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25000-117 IBUPROFEN TABLET [MARKSANS PHARMA LIMITED] 8 Current NDC, Legacy NDC, 13 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 25000-117-02 25000011702 1 BOTTLE in 1 CARTON (25000-117-02) / 24 TABLET in 1 BOTTLE 1 bottle 2019-12-20 0000-00-00 No No Current 25000-117-03 25000011703 30 TABLET in 1 BOTTLE (25000-117-03) 30 tablet 2011-07-25 0000-00-00 No No Current 25000-117-14 25000011714 1000 TABLET in 1 BOTTLE (25000-117-14) 1000 tablet 2011-07-25 0000-00-00 No No Current 25000-117-20 25000011720 4 BAG in 1 BOX (25000-117-20) / 6500 TABLET in 1 BAG 4 bag 2011-07-25 0000-00-00 No No Current 25000-117-30 25000011730 6 BAG in 1 BOX (25000-117-30) / 6500 TABLET in 1 BAG 6 bag 2011-07-25 0000-00-00 No No Current 25000-117-69 25000011769 300 TABLET in 1 BOTTLE (25000-117-69) 300 tablet 2011-07-25 0000-00-00 No No Current 25000-117-93 25000011793 1 BAG in 1 BOX (25000-117-93) / 37470 TABLET in 1 BAG 1 bag 2011-07-25 0000-00-00 No No Current 25000-117-98 25000011798 1 BAG in 1 BOX (25000-117-98) / 34065 TABLET in 1 BAG 1 bag 2011-07-25 0000-00-00 No No Current