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 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	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…`

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 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	8c3ca03e-0ec2-c15c-e053-2995a90ad8bd	2025-12-18	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 21130-396
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	7e2ab4f1-2e87-4fbf-8882-e4d20aef142c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
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
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
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 ndc (product): 0924-0076
Ibuprofen	IBUPROFEN	HEB	acf86f62-1d55-4281-95b7-8b2b51eb7c89	2025-09-10	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 37808-109
Ibuprofen	IBUPROFEN	HEB	c04ad0b4-5d8a-4861-9eaa-b2aaa7b19664	2025-09-10	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174 ndc (product): 37808-410
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 ndc (product): 47682-710
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 ndc (product): 47682-709 ndc (product): 47682-700 ndc (product): 47682-714
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
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
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

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 1 of 4 · 268 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9594	IBUPROFEN	IBUPROFEN	WALGREENS CO.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0761-0908	IBUPROFEN	IBUPROFEN	Basic Drugs, Inc.	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0076	Physicians Care Ibuprofen	Ibuprofen 200mg	Acme United Corporation	ANDA	Current
0924-0276	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
0924-0276	First Aid Only Ibuprofen	Ibuprofen	Acme United Corporation	ANDA	Current
11673-217	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
11673-248	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
11673-249	Ibuprofen	Ibuprofen	TARGET Corporation	ANDA	Current
21130-396	Ibuprofen	Ibuprofen	BETTER LIVING BRANDS LLC.	ANDA	Current
29485-7625	IBUPROFEN	IBUPROFEN 200MG	Mechanical Servants LLC	ANDA	Current
29485-7625	IBUPROFEN	IBUPROFEN 200MG	Mechanical Servants LLC	ANDA	Current
30142-249	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
30142-249	Ibuprofen	Ibuprofen	The Kroger Co.	ANDA	Current
33992-0568	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
33992-0568	Ibuprofen	Ibuprofen	ASSURED / DOLLAR TREE (Greenbrier International, Inc.)	ANDA	Current
35418-751	Zee Ibutab	Ibuprofen	Zee Medical Inc	ANDA	Current
36800-248	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-248	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-249	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-249	Ibuprofen	Ibuprofen	TOP CARE (Topco Associates LLC)	ANDA	Current
36800-969	Ibuprofen	Ibuprofen	TopCare	ANDA	Current
36800-969	Ibuprofen	Ibuprofen	TopCare	ANDA	Current
37808-109	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-109	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-410	Ibuprofen	Ibuprofen	HEB	ANDA	Current
37808-410	Ibuprofen	Ibuprofen	HEB	ANDA	Current
41163-509	Ibuprofen	Ibuprofen	SUPERVALU INC.	ANDA	Current
42961-043	Zee Ibutab	Ibuprofen	Cintas Corporation	ANDA	Current
42961-203	Xpect Ibuprofen	Ibuprofen	Cintas Corporation	ANDA	Current
42961-203	Xpect Ibuprofen	Ibuprofen	Cintas Corporation	ANDA	Current
44224-0018	Easy Care First Aid Ibuprofen	Ibuprofen	Tender Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-700	Medique Iprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-709	Medi-First Plus Ibuprofen	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-710	Green Guard Ibuprofen Relief	Ibuprofen	Unifirst First Aid	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corpor	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current
47682-714	Dover Addaprin	Ibuprofen	Unifirst First Aid Corporation	ANDA	Current