Application 091239

Type: ANDA
Sponsor: MARKSANS PHARMA

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 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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`e64feba35796…`

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	Grocery Outlet, Inc.	44660e1d-79c2-34ce-e063-6294a90ade3f	2026-03-17	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	Kroger Company	bc173f1b-2e44-2c2e-e053-2a95a90a89c4	2025-09-24	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 41226-600
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES,INC	f58d35f9-e44b-417b-98ce-0766b537cd2f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 49483-114 ndc (product): 49483-601 ndc (product): 49483-600
IBUPROFEN	IBUPROFEN	WALGREENS	7653b33c-7489-10db-e053-2991aa0ab508	2025-06-06	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 0363-9601
AeroTab Ibuprofen	IBUPROFEN TABLET	Aero Healthcare	ddd0f7fb-ae4b-c584-e053-2a95a90a0984	2025-02-26	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 55305-133
VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	a6d4ceb0-2b79-496a-aa1e-27edd507ced0	2024-12-10	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 68210-0800
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	746f79aa-3036-1b9b-e053-2a91aa0a1db6	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 0363-9600
IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	8e8684fa-095e-c6d6-e053-2a95a90a15b4	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 11673-990
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e86ae68-7687-79d6-e053-2995a90ac274	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 11673-991
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb613c44-e125-0f40-e053-2995a90a7ca5	2023-10-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb60e636-41fe-49fb-e053-2a95a90a0616	2023-09-29	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
ibuprofen	IBUPROFEN	DOLGENCORP INC	8f1358aa-495a-23da-e053-2995a90aa430	2023-01-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 55910-901
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7aa790a-6d6c-7929-e053-2995a90a1cf8	2022-01-04	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 11822-7891
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	3c8df1e5-61bc-4e70-b6b9-8973986ad589	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 25000-117 ndc (product): 25000-114
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239 ndc (product): 11822-7892

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9600	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9600	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9600	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9600	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9600	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9601	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9601	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9601	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-9601	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
11383-151	Ibuprofen	Ibuprofen	Weeks & Leo Co., Inc.	ANDA	Current
11673-990	IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-990	IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-991	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-991	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11822-7891	IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	ANDA	Current
11822-7891	IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	ANDA	Current
11822-7891	IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	ANDA	Current
11822-7892	IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	ANDA	Current
11822-7892	IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	ANDA	Current
12634-518	Ibuprofen	Ibuprofen	Apotheca, Inc	ANDA	Current
16103-396	Ibuprofen	Ibuprofen	Pharbest Pharmaceuticals, Inc.	ANDA	Current
25000-114	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-114	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-114	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-117	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-117	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-117	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
41226-600	IBUPROFEN	IBUPROFEN	Kroger Company	ANDA	Current
49483-114	Ibuprofen	Ibuprofen	TIME CAP LABORATORIES,INC	ANDA	Current
49483-114	Ibuprofen	Ibuprofen	TIME CAP LABORATORIES,INC	ANDA	Current
49483-600	IBUPROFEN	IBUPFROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-600	IBUPROFEN	IBUPFROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-600	IBUPROFEN	IBUPFROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-600	IBUPROFEN	IBUPFROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-600	IBUPROFEN	IBUPFROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-601	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-601	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-601	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-601	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
49483-601	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	ANDA	Current
50090-2463	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-2487	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
52605-114	Ibuprofen	Ibuprofen	Polygen Pharmaceuticals LLC	ANDA	Current
52605-117	Ibuprofen	Ibuprofen	Polygen Pharmaceuticals LLC	ANDA	Current
52904-447	Pain Relief	IBUPROFEN	Select Corporation	ANDA	Current
52904-486	Pain Relief Anti inflammatory	IBUPROFEN	Select Corporation	ANDA	Current
53002-5710	Ibuprofen	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5710	Ibuprofen	Ibuprofen	RPK Pharmaceuticals, Inc.	ANDA	Current
54348-836	Ibuprofen	Ibuprofen	Pharmpak, Inc.	ANDA	Current
54348-836	Ibuprofen	Ibuprofen	Pharmpak, Inc.	ANDA	Current
54473-308	CounterAct	Ibuprofen	Melaleuca, Inc	ANDA	Current
54473-308	CounterAct	Ibuprofen	Melaleuca, Inc	ANDA	Current
55305-133	AeroTab Ibuprofen	ibuprofen tablet	Aero Healthcare	ANDA	Current
55910-901	ibuprofen	ibuprofen	DOLGENCORP INC	ANDA	Current
55910-901	ibuprofen	ibuprofen	DOLGENCORP INC	ANDA	Current
61715-059	Ibuprofen	Ibuprofen	Kinray	ANDA	Current
61715-061	Ibuprofen	Ibuprofen	Kinray	ANDA	Current
61715-167	Ibuprofen	Ibuprofen	Kinray, Inc.	ANDA	Current
61786-948	IBUPROFEN	IBUPROFEN	REMEDYREPACK INC.	ANDA	Current
66424-396	Ibuprofen	Ibuprofen	SDA Laboratories, Inc.	ANDA	Current
67060-002	IBUPROFEN	IBUPROFEN 200MG	ADVANCED FIRST AID, INC.	ANDA	Current
68071-3074	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3074	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4563	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4563	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68210-0080	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0080	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0080	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0080	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0080	Assured Ibuprofen	Ibuprofen	Spirit Pharmaceutical LLC	ANDA	Current
68210-0800	VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	ANDA	Current
68210-0800	VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	ANDA	Current
68210-0800	VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	ANDA	Current
68210-0800	VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	ANDA	Current
68210-0800	VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	ANDA	Current
69168-383	Ibuprofen 200mg	383 Ibuprofen 200mg	Allegiant Health	ANDA	Current
69168-383	Ibuprofen 200mg	383 Ibuprofen 200mg	Allegiant Health	ANDA	Current
71335-0223	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
71335-0223	Ibuprofen	Ibuprofen	Bryant Ranch Prepack	ANDA	Current
76168-012	Ibuprofen	Ibuprofen	Velocity Pharma	ANDA	Current