Home NDC 83324-101 Ibuprofen
Product NDC 83324-101
11-digit product format 833240101
Labeler code 83324
Product ID 83324-101_53c38e7a-185f-a55e-e063-6394a90aede6
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION, INC.
Application ANDA079174
Marketing category ANDA
Marketing start 2025-05-08
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 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 A079174-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2010-12-10
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 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 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
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.
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 3 of 4 · 70 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN AMERIFOODS TRADING COMPANY f6dc62db-f728-66fc-e053-6394a90a96b3 2025-07-15 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 IBUPROFEN IBUPROFEN AMERIFOODS TRADING COMPANY f6dc2a73-046b-6b93-e053-6294a90ab295 2025-07-15 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 7b2f7a68-8f5e-a340-e053-2991aa0a5aeb 2025-07-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 IBUPROFEN IBUPROFEN AAA Pharmaceutical, Inc. 1e686091-6456-36c8-e063-6294a90a3866 2025-06-17 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN FSA STORE INC. ec6b015d-e72e-89c4-e053-2a95a90af81c 2025-06-17 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Marc Glassman, Inc. 47434f23-5ac9-4cb4-a963-7c8bf9e06361 2025-06-11 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Marc Glassman, Inc. 3b0e4ccc-cc0b-42fb-9163-7560740d9592 2025-06-11 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Redicare Ibuprofen 200mg IBUPROFEN 200MG Redicare LLC 2f0db953-33e2-1729-e063-6294a90af074 2025-03-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Bi-Mart 7ceacd63-d5fa-4cab-b8f3-a5131c97bb90 2025-02-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN BI-MART 34440532-03e1-4feb-b3e2-dab869edeb15 2025-02-01 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen, Caseys 4good IBUPROFEN TABLETS Lil' Drug Store Products, Inc. 04b3ad8b-bdf9-47f3-e063-6294a90ac350 2024-12-31 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC 59c77fd3-5e67-45ec-82ad-44585390c4f3 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC a96d012e-b132-4e99-b84b-ccd3a9a05cbb 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Cabinet Pain Reliever and Fever Reducer IBUPROFEN Spirit Pharmaceutical LLC e172a8d8-779d-4ad9-b6b0-08a198a58034 2024-12-30 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceutical LLC 9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af 2024-12-20 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Dolgencorp, Inc. 5398f5b7-a9a6-4f7e-a06c-e524b9939562 2024-12-19 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Spirit Pharmaceuticals LLC e38d23e5-b455-41b5-86f6-c318b17bd345 2024-12-13 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Winco Foods, LLC 428b011f-d7d3-4a3b-87dd-d4e84e90cabd 2024-12-06 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Winco Foods, LLC 60130bdc-6f45-4998-b53a-cad6cbf25036 2024-12-06 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Ibuprofen IBUPROFEN Granules India Limited fd01353d-1d1d-42b5-9a03-575052189bf5 2024-08-13 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-101-25 83324010125 250 TABLET, COATED in 1 PACKAGE (83324-101-25) 2025-05-08 No No Current