Home NDC 53746-142-10 Ibuprofen
Product NDC 53746-142
Requested package NDC 53746-142-10
11-digit product format 537460142
Labeler code 53746
Product ID 53746-142_ef67c08a-fc4f-4e6c-a58f-8ed743b2b6aa
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA072199
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53746-142 53746-142-10 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53746-142 53746-142-10 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A072199-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1988-05-23
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 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072199-001 IBUPROFEN 200MG TABLET / ORAL 1988-05-23 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 (NSAID) 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 53746-142-01 Ibuprofen(NSAID) Pain Releiver/ Fever Reducer 100 in 1 BOTTLE TABLET 100 11 53746-142-10 Ibuprofen(NSAID) Pain Releiver/ Fever Reducer 1000 in 1 BOTTLE TABLET 1000 11 53746-142-24 Ibuprofen(NSAID) Pain Releiver/ Fever Reducer 24 in 1 BOTTLE TABLET 24 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-142 IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 11 Current NDC, Legacy NDC, 3 package rows 20240101_a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0.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 53746-142-10 53746014210 1000 TABLET in 1 BOTTLE (53746-142-10) 1000 tablet 2009-12-16 0000-00-00 No No Current