Home NDC 53329-674 Ibuprofen
Product NDC 53329-674
11-digit product format 533290674
Labeler code 53329
Product ID 53329-674_536feefb-4af9-5c62-e063-6294a90a3c95
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Medline industries, LP
Application ANDA079174
Marketing category ANDA
Marketing start 2017-09-29
Marketing end 2027-06-30
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
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 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 53329-674-30 Ibuprofen 100 in 1 BOTTLE TABLET 100 8 53329-674-30 Ibuprofen 1 in 1 CARTON TABLET 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-674 IBUPROFEN TABLET [MEDLINE INDUSTRIES, LP] 8 Current NDC, Legacy NDC, 2 package rows 20230810_5d2482b4-cd90-4246-85a9-fd1d35315b6c.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 3 of 4 · 67 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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, 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 IBUPROFEN 200 MG IBUPROFEN Basic Drugs, Inc. d3351d44-2078-3adc-e053-2995a90a3c8f 2024-01-03 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Circle K Ibuprofen IBUPROFEN Lil Drug Store Products, Inc 791a7375-34b2-449b-9284-3c49a2704619 2022-10-11 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174 Pain Relief - Ibuprofen 200 mg IBUPROFEN Health Pharma USA LLC d60a6a11-8c06-cede-e053-2a95a90af7f9 2022-01-20 Warnings Exact identifier application applno (ANDA): 079174 application number: ANDA079174
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 53329-674-30 53329067430 1 BOTTLE in 1 CARTON (53329-674-30) / 100 TABLET in 1 BOTTLE 1 bottle 2017-09-29 2027-06-30 No No Current