Application 076925

Type: ANDA
Sponsor: L PERRIGO CO

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 1.

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
A076925-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB		2004-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076925-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076925-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2004-09-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076925-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076925-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076925-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076925-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076925-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076925-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076925-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076925-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076925-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076925-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076925-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076925-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076925-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076925-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076925-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076925-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076925-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076925-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076925-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076925-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076925-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076925-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076925-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076925-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076925-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076925-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076925-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076925-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076925-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076925-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076925-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076925-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076925-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076925-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076925-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076925-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076925-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076925-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076925-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076925-001	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	998f2fcf-0b40-4304-929f-7f2fa42f66d0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076925 application number: ANDA076925 ndc (product): 45802-952
Ibuprofen	IBUPROFEN	Proficient Rx LP	9e9fb921-6b6a-422e-95b6-41d6b9047b80	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076925 application number: ANDA076925 ndc (product): 71205-716

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-1548	IBUPROFEN	IBUPROFEN	Pharmaceutical Associates, Inc.	ANDA	Current
0121-4774	IBUPROFEN	IBUPROFEN	Pharmaceutical Associates, Inc.	ANDA	Current
21695-420	Ibuprofen	Ibuprofen	Rebel Distributors Corp	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-952	Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
49999-928	Ibuprofen	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0707	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
68788-9067	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-716	Ibuprofen	Ibuprofen	Proficient Rx LP	ANDA	Current
81646-113	Ibuprofen	Ibuprofen	PINNACLE PHARMA LLC	ANDA	Current