Application 205647

Type: ANDA
Sponsor: HI TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	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
A205647-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2016-11-03

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2016-11-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205647-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2016-11-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205647-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205647-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205647-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205647-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205647-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205647-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205647-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205647-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205647-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205647-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205647-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205647-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205647-001	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A205647-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205647-001	AB	1	`cb3db0bc1861…`

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 24 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Chain Drug Consortium	6c593a9c-680e-4645-8e8f-d8d044c92ca1	2025-07-18	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	a88020c0-7982-4307-9836-74de66ea47a5	2025-07-17	Warnings	Name fallback generic name: IBUPROFEN
profen ib infants	IBUPROFEN	Publix Super Markets Inc	84aea3fc-4f3b-4a76-a3a6-94ed6549dbea	2025-07-17	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	cfe27d2a-b602-4b3e-bdcb-14fed4a236ca	2025-07-17	Warnings	Name fallback generic name: IBUPROFEN
Dg Health Ibuprofen	IBUPROFEN	Dolgencorp, LLC	9022e393-084e-499b-ac84-f35360d79592	2025-07-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Demoulas Super Markets, Inc	39802e26-1028-d2fe-e063-6394a90a24c7	2025-07-16	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AMERIFOODS TRADING COMPANY	f6dc62db-f728-66fc-e053-6394a90a96b3	2025-07-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	7f366669-9d31-46c7-932d-02fa64b11f30	2025-07-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	9714e804-fadb-103d-e053-2a95a90ad765	2025-07-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	AMERIFOODS TRADING COMPANY	f6dc2a73-046b-6b93-e053-6294a90ab295	2025-07-15	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	9714de6b-068b-d6b9-e053-2995a90a3b27	2025-07-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Kroger Company	91da5b64-db7f-4954-89e8-977b31247f9c	2025-07-11	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d	2025-07-11	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Safeway	0fe94b11-f7c9-4e32-976f-e5f11d01bd64	2025-07-09	Warnings	Name fallback generic name: IBUPROFEN
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	cf330b44-2d69-4f9f-99eb-2caa80aca873	2025-07-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	6cf3328b-da8f-4f6b-8237-16a4d6b9c833	2025-07-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	f4dad3d6-1366-4bdf-99eb-370ab74a6b9e	2025-07-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	Dr. Reddy's Laboratories Limited	24731405-219c-79b4-ecf0-7d5fbfda94ba	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ibuprofen 200	IBUPROFEN	Walgreen Company	49a3d51d-55d1-4b80-ab7b-35c27a937cb9	2025-07-02	Warnings	Name fallback generic name: IBUPROFEN

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 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Akorn	ANDA	Current
50383-584	Ibuprofen	Ibuprofen	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
55154-9628	Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current