Application 206568

Type: ANDA
Sponsor: HUMANWELL PURACAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	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
A206568-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2016-06-21

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	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`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 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen minis	IBUPROFEN	The Kroger Co.	15709fa7-114b-453c-b63d-f1c4f28f0f95	2026-09-08	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	The Kroger Co.	a7789f7f-3356-463b-9fd7-2d7f7eba2799	2026-09-08	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen minis	IBUPROFEN	Walgreens	6d1d131d-0741-4a75-8383-9322f4f3faab	2026-08-06	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	Safeway, Inc.	a530d43d-e9c4-4edb-af66-c92860e46f45	2026-07-23	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	P & L Development, LLC	d0301d0d-fc65-420f-87fd-a08da1584d54	2026-06-08	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen Minis	IBUPROFEN	Vivunt Pharma LLC	c46803db-feb7-435c-ac42-cffa99d35f46	2026-06-04	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	CVS Pharmacy	121b13c8-0b1a-4c48-9d57-3b53a9228d34	2026-05-22	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568 ndc (product): 69842-745
Ibuprofen minis	IBUPROFEN	CVS Pharmacy	a6fc144a-6826-4bf7-8efb-8cdb896387f1	2026-05-12	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568 ndc (product): 69842-643
Ibuprofen minis	IBUPROFEN	Safeway, Inc.	22927a12-6837-4d57-8e60-043000f2f208	2026-01-05	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	46a9424c-fd7d-f88b-e063-6294a90abceb	2025-12-24	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	3a02af7e-7e69-45a6-97d7-ddc7d92b28b3	2025-10-22	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen Minis	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	72f933d8-cf01-4bb6-a552-e3cdb297038b	2025-10-21	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	CVS Pharmacy	e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c	2025-07-01	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568 ndc (product): 69842-649
Ibuprofen	IBUPROFEN	Chain Drug Consortium, LLC	f0f01b97-e52c-4077-a4c6-c59736f4c171	2025-06-30	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568 ndc (product): 68016-813
Ibuprofen minis	IBUPROFEN	P & L Development, LLC	18b79fc5-57c8-46f1-81f3-2f9e189cdbcb	2025-05-16	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	AAFES/Your Military Exchanges	773b0230-a3a3-44e0-a22b-d143796ca365	2025-05-08	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen minis	IBUPROFEN	WR Group, Inc.	e9dad35a-6789-42d6-97da-521db7b16496	2025-03-24	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	Care One (Retail Business Services, LLC.)	a6ce7484-7a32-4985-80bc-883c31be3525	2025-03-12	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568 ndc (product): 72476-745
Ibuprofen	IBUPROFEN	Rugby Laboratories, Inc.	05c4e6c7-bf95-4e05-b7da-7a8778de342b	2024-10-28	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568
Ibuprofen	IBUPROFEN	P & L Development, LLC	1f9c94a6-938a-420f-b90c-36b3791e97ad	2024-10-07	Warnings	Exact identifier application applno (ANDA): 206568 application number: ANDA206568

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 3 · 214 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63868-239	Ibuprofen	Ibuprofen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-281	Ibuprofen	Ibuprofen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-281	Ibuprofen	Ibuprofen	Chain Drug Marketing Association Inc.	ANDA	Current
63868-295	Ibuprofen	Ibuprofen	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63868-295	Ibuprofen	Ibuprofen	QUALITY CHOICE (Chain Drug Marketing Association)	ANDA	Current
63941-745	Ibuprofen	Ibuprofen	Best Choice (Valu Merchandisers Company)	ANDA	Current
63941-745	Ibuprofen	Ibuprofen	Best Choice (Valu Merchandisers Company)	ANDA	Current
63941-745	Ibuprofen	Ibuprofen	Best Choice (Valu Merchandisers Company)	ANDA	Current
63941-745	Ibuprofen	Ibuprofen	Best Choice (Valu Merchandisers Company)	ANDA	Current
68016-813	Ibuprofen	Ibuprofen	Chain Drug Consortium, LLC	ANDA	Current
68196-745	Ibuprofen	Ibuprofen	Sam's West, Inc	ANDA	Current
68196-745	Ibuprofen	Ibuprofen	Sam's West, Inc	ANDA	Current
68196-745	Ibuprofen	Ibuprofen	Sam's West, Inc	ANDA	Current
68196-745	Ibuprofen	Ibuprofen	Sam's West, Inc	ANDA	Current
68196-980	Ibuprofen	Ibuprofen	Sam's West, Inc.	ANDA	Current
68196-980	Ibuprofen	Ibuprofen	Sam's West, Inc.	ANDA	Current
68196-981	Ibuprofen	Ibuprofen	Sam's West, Inc.	ANDA	Current
68196-981	Ibuprofen	Ibuprofen	Sam's West, Inc.	ANDA	Current
69256-843	Ibuprofen minis	Ibuprofen	Harris Teeter, LLC	ANDA	Current
69256-843	Ibuprofen minis	Ibuprofen	Harris Teeter, LLC	ANDA	Current
69842-170	Ibuprofen	Ibuprofen	CVS PHARMACY, INC.	ANDA	Current
69842-170	Ibuprofen	Ibuprofen	CVS PHARMACY, INC.	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-643	Ibuprofen minis	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-649	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-649	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-649	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-649	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
69842-745	Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70000-0360	Ibuprofen	Ibuprofen	Cardinal Health (Leader) 70000	ANDA	Current
70729-000	Ibuprofen Softgels	ibuprofen	Breeden Brothers, LLC	ANDA	Current
70729-509	Ibuprofen Softgels	ibuprofen	Breeden Brothers, LLC	ANDA	Current
72476-745	Ibuprofen	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-745	Ibuprofen	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-843	Ibuprofen minis	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-843	Ibuprofen minis	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-843	Ibuprofen minis	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-843	Ibuprofen minis	Ibuprofen	Care One (Retail Business Services, LLC.)	ANDA	Current