Home NDC 72090-070-01 Ibuprofen
Product NDC 72090-070
Requested package NDC 72090-070-01
11-digit product format 720900070
Labeler code 72090
Product ID 72090-070_07bae792-e529-4828-aef7-85c9700fb3fb
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application ANDA079129
Marketing category ANDA
Marketing start 2026-07-29
Substance IBUPROFEN
Active strength 200 mg/1
Pharmacologic classes Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing certified through 2027-12-31
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 A079129-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2011-03-28
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 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 15 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 8abd74a4-ad33-4c10-b677-acb469f815e6 2026-08-03 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 ndc (package): 72090-070-01 ndc (product): 72090-070 ndc11 (package): 72090007001 Ibuprofen IBUPROFEN NUVICARE LLC 7905edc1-2a45-4adc-a7bc-42b1ddb6ba59 2026-08-03 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) 5beb7c11-4ed4-4cd4-9c30-3b0c4016316f 2026-05-27 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c 2026-05-27 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 IBUPROFEN Immediate Release IBUPROFEN Strides Pharma Inc a5dd275f-f388-44ec-8297-74430a742d52 2026-03-24 Boxed warning, Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 CVS Ibuprofen IBUPROFEN CVS Pharmacy 3d71e29f-0648-7377-e063-6294a90a8a29 2026-02-17 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN Strategic Sourcing Services, LLC dc469eb2-89cc-46c9-9304-f6cf119c0570 2026-01-29 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN AAA Pharmaceutical, Inc. fbc7fb61-d295-464b-9f3b-52262ed6f31a 2025-12-09 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 RIGHT REMEDIES Ibuprofen 200 MG IBUPROFEN Strive Pharmaceuticals Inc. 5c155210-d16f-487e-983d-c7b0f97365c6 2025-10-08 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN AAA Pharmaceutical, Inc. 39e55ec1-213f-4996-adca-68a5ffbc409b 2024-12-06 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN P & L Development, LLC 6d1c9a64-c83c-4b3d-9245-704b94cb367c 2024-07-30 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen, Circle K, 50ct IBUPROFEN Lil' Drug Store Products, Inc. 1ab6fbae-ead5-283b-e063-6394a90a4ed4 2024-06-12 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) eaa0a286-a0f0-4979-8af3-c5f4194283fd 2023-06-22 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Flex-Prin IBUPROFEN Provision Medical Products c01538b0-ca4c-434a-be8f-fe023deb84e1 2023-01-05 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen Fast relief medicine for pain IBUPROFEN 200 MG Allegiant Health dd63b011-0573-4374-9669-8d29146e5fc9 2017-11-17 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 72090-070-01 72090007001 500 TABLET in 1 BOTTLE (72090-070-01) 500 tablet 2026-07-29 0 Current