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 21 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	CVS Pharmacy. Inc.	d4336a7c-fb9f-1fbe-e053-2995a90af365	2025-09-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy.Inc.	cd0c3404-9e9d-bfad-e053-2995a90a8719	2025-09-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	A-S Medication Solutions	7d4ba8be-df59-4a21-8850-8a59bf72b604	2025-09-11	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	894a5d14-e405-43ac-a5a2-0b4de5b28474	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HEB	acf86f62-1d55-4281-95b7-8b2b51eb7c89	2025-09-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	HEB	c04ad0b4-5d8a-4861-9eaa-b2aaa7b19664	2025-09-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Green Guard Ibupro relief	IBUPROFEN	Unifirst First Aid Corporation	2923c4a3-f994-67a7-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	2910b50b-c8de-382b-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Green Guard Ibuprofen Relief	IBUPROFEN	Unifirst First Aid	0798e401-8247-2fce-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique at Home Iprin	IBUPROFEN	Unifirst First Aid Corporation	b5547f33-2a81-867d-e053-2995a90aa2d0	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Medique Iprin	IBUPROFEN	Unifirst First Aid Corporation	0607edb0-1b3a-2ccd-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	28d45743-d298-29db-e054-00144ff8d46c	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Unishield Ibuprofen	IBUPROFEN	Unishield	b9e2e2ba-e2ad-eace-e053-2995a90aed35	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Direct Safety Ibuprofen	IBUPROFEN	Conney Safety Products, LLC	07afce34-aaea-50a1-e054-00144ff88e88	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Uline Ibuprofen	IBUPROFEN	Uline	d7342a15-9d49-74ed-e053-2a95a90a22cc	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
McKesson Ibuprofen 200 mg	IBUPROFEN	McKesson Medical-Surgical	ca75b9fe-5bc8-ab90-e053-2995a90a52fb	2025-09-09	Warnings	Name fallback generic name: IBUPROFEN
Henry Schein Ibuprofen	IBUPROFEN	Henry Schein Inc.	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Thompson	IBUPROFEN	Thompson Safety	ccfbc048-f666-3188-e053-2995a90ae08f	2025-09-08	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Walgreen Company	37c9b887-190a-4daf-8199-f406913132f0	2025-09-03	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sam's West Inc	6293a134-860d-4d12-9e4b-28490f824108	2025-09-03	Warnings	Name fallback brand name: Ibuprofen 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