Home NDC 63868-983-25 Ibuprofen
Product NDC 63868-983
Requested package NDC 63868-983-25
11-digit product format 638680983
Labeler code 63868
Product ID 63868-983_cdc44784-5ba0-d65c-e053-2995a90ad6e8
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler Chain Drug Marketing Association
Application ANDA079129
Marketing category ANDA
Marketing start 2012-08-27
Marketing end 2023-04-30
Substance IBUPROFEN
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 1
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 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 Marketing start Marketing end Sample Exclude flag Status 63868-983-25 63868098325 250 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-983-25) 2012-08-27 2023-04-30 No No Current