Application 079113

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	TABLET;ORAL	38MG;200MG	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
A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL			2008-12-22

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079113-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2008-12-22	`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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good neighbor pharmacy ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Amerisource Bergen	2829ee62-7685-4dbb-9f61-4ee0fb19e4c6	2026-05-15	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Meijer Distribution Inc	47e71e23-da8a-4759-ac5a-1d48e0d9ab98	2026-04-22	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Care One Ibuprofen PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	American Sales Company	d5bf76d1-6fed-4f6b-8507-3e8973295d67	2026-04-01	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Rite Aid Corporation	d9eefb84-cc2e-4deb-a1c0-a7c21929f5ac	2026-03-27	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
up and up ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Target Corporation	0c764683-f3c9-4382-96be-d34b7a582aee	2026-03-16	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	HyVee Inc	833a2bee-0e55-44f7-b80d-b336ebe52fc9	2026-01-14	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
IBUPROFEN PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Safeway	57e8f0d7-1f21-4fda-8b21-3caa54fae4e6	2026-01-02	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	CVS Pharmacy	44e4e54b-cb40-4b7c-a141-181bde62a69f	2025-10-24	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Motrin PM	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Kenvue Brands LLC	55403f19-58ae-450b-8a7b-0bc544088f20	2025-07-11	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Kroger Company	347dd263-ba0d-4a5a-8ac8-e586fcfd014e	2025-06-23	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Walgreen Company	9c5c1f48-d285-4faa-96d0-b04f435c9c5c	2025-06-23	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	H E B	2114b2a9-f9af-43b9-97ec-859a4afe7ec8	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
good sense ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	L. Perrigo Company	0488786f-9b6b-4935-bb57-bcb2565447f8	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Topcare Ibuprofen PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Topco Associates LLC	1435e627-144e-4dc8-9ad6-58d91cbd9094	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
equaline ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	United Natural Foods, Inc. dba UNFI	5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Exchange Select Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Army & Air Force Exchange Service	56761c01-48f2-4d17-a607-6639fb3a7a98	2025-04-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
equate ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Wal-Mart Stores Inc	e36957ed-653c-465f-8150-7d6073e1376f	2025-03-16	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113
Leader Ibuprofen PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Cardinal Health 110, LLC. dba Leader	b19ad305-4464-4404-a011-584fa0c08521	2024-11-21	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113 ndc (product): 70000-0157
basic care ibuprofen pm	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Amazon.com Services LLC	6bd8bad2-4370-4450-822a-9ef50949a8fc	2024-09-09	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113 ndc (product): 72288-050
dg health Ibuprofen pm	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Dolgencorp Inc	4bbe40de-0957-4705-893d-fcb4191885c9	2024-01-22	Warnings	Exact identifier application applno (ANDA): 079113 application number: ANDA079113

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 87 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70000-0157	Leader Ibuprofen PM	diphenhydramine citrate, ibuprofen	Cardinal Health	ANDA	Current
70000-0157	Leader Ibuprofen PM	diphenhydramine citrate, ibuprofen	Cardinal Health	ANDA	Current
70000-0157	Leader Ibuprofen PM	diphenhydramine citrate, ibuprofen	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0248	Leader Ibuprofen PM	Diphenhydramine citrate, Ibuprofen	Cardinal Health	ANDA	Current
70000-0248	Leader Ibuprofen PM	Diphenhydramine citrate, Ibuprofen	Cardinal Health	ANDA	Current
72288-050	basic care ibuprofen pm	diphenhydramine citrate, ibuprofen	Amazon.com Services LLC	ANDA	Current
72288-050	basic care ibuprofen pm	diphenhydramine citrate, ibuprofen	Amazon.com Services LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22634	ORIG	2012-03-28