sunmark ibuprofen pm

Product NDC: 49348-873
11-digit product format: 493480873
Labeler code: 49348
Product ID: 49348-873_ecacf39d-3cba-406e-af9d-3d5c8a439cb5
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine citrate and ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA079113
Marketing category: ANDA
Marketing start: 2009-02-18
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49348-873		D	Discontinued by firm		2026-08-10
excluded package	package	49348-873	49348-873-59	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-873-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-873-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-873-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-873-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-873-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-873-59	`cdf11ea48f46…`	`ba0047e9e063…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-873-59	EA - Each	49348-873	c26bac59-4735-44f2-a5ce-9cca20d24997	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE CITRATE	ACTIVE INGREDIENT	4OD433S209	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUNMARK IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [MCKESSON]	2

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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-873-59	49348087359	1 BOTTLE in 1 CARTON (49348-873-59) > 40 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Ibuprofen PM Drug Facts	Strategic Sourcing Services LLC	2024-12-23	HUMAN OTC DRUG LABEL	7