Application 079174

Type: ANDA
Sponsor: GRANULES INDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c2088c7a36db…`
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…`

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 2 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	7e2ab4f1-2e87-4fbf-8882-e4d20aef142c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 63941-109
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	02e4418a-93ed-2212-e063-6294a90a6c8a	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	88b3f388-46d3-4e42-98fb-0351c76a15fc	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 63941-210
Lil Drug Store Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	c3be5923-9299-49b0-a455-e0c1c86985a8	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 66715-6920
CAREALL Ibuprofen	IBUPROFEN	New World Imports	246cf64a-162d-47a4-910a-9fb0b9be3dd1	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f099a-ee59-0b9a-e053-2a95a90a2fe1	2025-11-18	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f308f-0ca5-12fa-e053-2995a90a47fc	2025-11-18	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Physicians Care Ibuprofen	IBUPROFEN 200MG	Acme United Corporation	490e551c-0e80-3d95-e054-00144ff8d46c	2025-10-31	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	HEB	acf86f62-1d55-4281-95b7-8b2b51eb7c89	2025-09-10	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	HEB	c04ad0b4-5d8a-4861-9eaa-b2aaa7b19664	2025-09-10	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Green Guard Ibuprofen Relief	IBUPROFEN	Unifirst First Aid	0798e401-8247-2fce-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	0607edb0-1b3a-2ccd-e054-00144ff8d46c	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	07afce34-aaea-50a1-e054-00144ff88e88	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 61245-084
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
McKesson Ibuprofen 200 mg	IBUPROFEN	McKesson Medical-Surgical	ca75b9fe-5bc8-ab90-e053-2995a90a52fb	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 68599-8051
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0e95aab9-3a7c-49c3-b8df-f66d6f31aee0	2025-07-31	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	AMERIFOODS TRADING COMPANY	f6dc62db-f728-66fc-e053-6394a90a96b3	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 3 of 4 · 268 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59726-568	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-568	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-568	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-661	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-661	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-661	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
59726-661	Ibuprofen	Ibuprofen	P & L Development, LLC	ANDA	Current
61245-084	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-084	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-084	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-084	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
61245-084	Direct Safety Ibuprofen	Ibuprofen	Conney Safety Products, LLC	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-365	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-366	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-395	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-395	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-395	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-395	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-395	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-396	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-396	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-396	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-396	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
62207-396	Ibuprofen	Ibuprofen	Granules India Limited	ANDA	Current
63868-268	Ibuprofen	Ibuprofen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63941-109	Ibuprofen	Ibuprofen	VALU MERCHANDISERS COMPANY	ANDA	Current
63941-210	Ibuprofen	Ibuprofen	VALU MERCHANDISERS COMPANY	ANDA	Current
66715-5507	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-5507	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6707	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6707	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6707	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6707	Circle K Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6839	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6839	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6839	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6920	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6920	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
66715-6920	Lil Drug Store Ibuprofen	Ibuprofen	Lil Drug Store Products, Inc	ANDA	Current
67060-001	IBUPROFEN	IBUPROFEN 200MG	ADVANCED FIRST AID, INC.	ANDA	Current
67091-347	Ibuprofen	Ibuprofen	Winco Foods, LLC	ANDA	Current
67091-348	Ibuprofen	Ibuprofen	Winco Foods, LLC	ANDA	Current
68210-0026	Cabinet Pain Reliever and Fever Reducer	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0026	Cabinet Pain Reliever and Fever Reducer	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0026	Cabinet Pain Reliever and Fever Reducer	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0081	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0081	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-4140	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-4140	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-4140	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-4192	Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4192	Ibuprofen	Ibuprofen	Spirit Pharmaceuticals LLC	ANDA	Current
68210-6114	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-6114	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-8100	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-8100	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-8100	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-8100	Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68599-8051	McKesson Ibuprofen 200 mg	Ibuprofen	McKesson Medical-Surgical	ANDA	Current
68599-8051	McKesson Ibuprofen 200 mg	Ibuprofen	McKesson Medical-Surgical	ANDA	Current
68599-8051	McKesson Ibuprofen 200 mg	Ibuprofen	McKesson Medical-Surgical	ANDA	Current
68998-109	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
68998-109	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
68998-110	Ibuprofen	Ibuprofen	Marc Glassman, Inc.	ANDA	Current
69168-381	Ibuprofen 200mg	Ibuprofen	Allegiant Health	ANDA	Current
69168-381	Ibuprofen 200mg	Ibuprofen	Allegiant Health	ANDA	Current
69168-381	Ibuprofen 200mg	Ibuprofen	Allegiant Health	ANDA	Current
69168-382	Ibuprofen 200mg	Ibuprofen 200mg	Allegiant Health	ANDA	Current
69168-382	Ibuprofen 200mg	Ibuprofen 200mg	Allegiant Health	ANDA	Current
69517-111	Fast Pain Relief	Ibuprofen	HealthLife of USA LLC	ANDA	Current