Home NDC 53746-140-01 Ibuprofen
Product NDC 53746-140
Requested package NDC 53746-140-01
11-digit product format 537460140
Labeler code 53746
Product ID 53746-140_e2b9bf54-0449-4f9b-86e8-e3b292387dd5
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA071333
Marketing category ANDA
Marketing start 2009-12-16
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 43 .
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 A071333-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1987-02-17
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 · 43 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 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071333-001 IBUPROFEN 200MG TABLET / ORAL 1987-02-17 f41ea6bd6efb…
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
Brand name suffix Pain Releiver/ Fever Reducer
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-140-01 IbuprofenPain Releiver/ Fever Reducer 100 in 1 BOTTLE TABLET 100 16 53746-140-10 IbuprofenPain Releiver/ Fever Reducer 1000 in 1 BOTTLE TABLET 1000 16 53746-140-24 IbuprofenPain Releiver/ Fever Reducer 24 in 1 BOTTLE TABLET 24 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-140 IBUPROFEN PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 16 Current NDC, Legacy NDC, 3 package rows 20240101_ee241be0-35f8-4789-a71f-98de31d6a590.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 · 1 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 53746-140-01 53746014001 100 TABLET in 1 BOTTLE (53746-140-01) 100 tablet 2009-12-16 0000-00-00 No No Current