Home NDC 53746-132-60 Ibuprofen
Product NDC 53746-132
Requested package NDC 53746-132-60
11-digit product format 537460132
Labeler code 53746
Product ID 53746-132_fc9fc973-31c3-42df-93e7-eeeeb280bcaa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA071335
Marketing category ANDA
Marketing start 2009-01-05
Substance IBUPROFEN
Active strength 600 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 A071335-001 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071335-001 AB
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 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071335-001 IBUPROFEN 600MG TABLET / ORAL AB 1986-11-25 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 600 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 197806 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# NDC, Effective, Related label table NDC Effective Related label 53746-132-01 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-05 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-30 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-50 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-60 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-90 2021-03-18 IBUPROFEN TABLETS, USP 53746-132-01 2021-01-29 IBUPROFEN TABLETS, USP 53746-132-05 2021-01-29 IBUPROFEN TABLETS, USP 53746-132-30 2021-01-29 IBUPROFEN TABLETS, USP 53746-132-50 2021-01-29 IBUPROFEN TABLETS, USP 53746-132-60 2021-01-29 IBUPROFEN TABLETS, USP 53746-132-90 2021-01-29 IBUPROFEN TABLETS, USP
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-132 IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 14 Current NDC, Legacy NDC, 6 package rows 20241222_8df77ead-27eb-4f6f-95a9-f68d3e9cfa71.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 53746-132-60 53746013260 60 TABLET in 1 BOTTLE (53746-132-60) 60 tablet 2009-01-05 0000-00-00 No No Current