Home NDC 57896-941-25 Ibuprofen
Product NDC 57896-941
Requested package NDC 57896-941-25
11-digit product format 578960941
Labeler code 57896
Product ID 57896-941_08f1bde2-f476-2d2f-e063-6294a90a6f93
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Geri-Care Pharmaceutical Corp
Application ANDA075010
Marketing category ANDA
Marketing start 2004-01-01
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A075010-001 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.
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 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57896-941-01 Ibuprofen 100 in 1 BOTTLE TABLET, FILM COATED 100 6 57896-941-05 Ibuprofen 50 in 1 BOTTLE TABLET, FILM COATED 50 6 57896-941-10 Ibuprofen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6 57896-941-20 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 6 57896-941-20 Ibuprofen 200 in 1 BOTTLE TABLET, FILM COATED 200 6 57896-941-25 Ibuprofen 250 in 1 BOTTLE TABLET, FILM COATED 250 6 57896-941-50 Ibuprofen 500 in 1 BOTTLE TABLET, FILM COATED 500 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-941 IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] 6 Current NDC, Legacy NDC, 7 package rows 20231031_0744c3ca-4224-4f6a-a033-880949b544fd.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 3 · 53 matching rows.
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 57896-941-25 57896094125 250 TABLET, FILM COATED in 1 BOTTLE (57896-941-25) 2017-09-01 0000-00-00 No No Current