Home NDC 59556-857 IBUPROFEN
Product NDC 59556-857
11-digit product format 595560857
Labeler code 59556
Product ID 59556-857_31a2c138-64f4-4ce0-ab02-d227240737dd
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form TABLET, COATED
Route ORAL
Labeler Strides Pharma Inc
Application ANDA079129
Marketing category ANDA
Marketing start 2022-03-18
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A079129-001 IBUPROFEN 200MG TABLET / ORAL 2011-03-28 caaa826d4ba7…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…
Additional Listing Data#
Finished product Yes
Brand name base IBUPROFEN
Brand name suffix Immediate Release
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 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 59556-857-42 IBUPROFENImmediate Release 10000 in 1 BAG TABLET, COATED 10000 6 59556-857-43 IBUPROFENImmediate Release 30000 in 1 BAG TABLET, COATED 30000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59556-857 IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC] 4 Current NDC, Legacy NDC, 2 package rows 20240523_a5dd275f-f388-44ec-8297-74430a742d52.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 · 16 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN P & L Development, LLC 159b68b7-54e5-4f83-b632-f49e7b4b14a5 2026-08-05 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 Ibuprofen IBUPROFEN Pioneer Life Sciences, LLC 8abd74a4-ad33-4c10-b677-acb469f815e6 2026-08-03 Warnings Exact identifier application applno (ANDA): 079129 application number: ANDA079129 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 ndc (product): 59556-857 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
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 59556-857-42 59556085742 10000 TABLET, COATED in 1 BAG (59556-857-42) 2022-03-18 0000-00-00 No No Current 59556-857-43 59556085743 30000 TABLET, COATED in 1 BAG (59556-857-43) 2023-06-01 No No Current