Zolpidem Tartrate

Product NDC: 63739-526
11-digit product format: 637390526
Labeler code: 63739
Product ID: 63739-526_c19a2d17-4509-d821-e053-2995a90aed7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA078413
Marketing category: ANDA
Marketing start: 2007-05-04
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 10 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63739-526		D	Discontinued by firm		2026-08-03
excluded package	package	63739-526	63739-526-10	D	Discontinued by firm		2026-08-03

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 · 22 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	63739-526-10	`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	63739-526-10	`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	63739-526-10	`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	63739-526-10	`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	63739-526-10	`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	63739-526-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63739-526-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63739-526-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63739-526-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63739-526-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63739-526-10	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078413-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-05-04
A078413-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078413-001	AB
A078413-002	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 3 · 82 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	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078413-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078413-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078413-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078413-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078413-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078413-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078413-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078413-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078413-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078413-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078413-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078413-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078413-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078413-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078413-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-526-10	2020-07-22	C162847	48780-1	ab0e2407-292c-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use, CIV Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-526-10	EA - Each	63739-526	253ed8cf-ef19-45a4-a0d9-a8c7a797fdf2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]	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 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	91511d2f-7066-49a0-90ea-2940d955c85e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	ef72eb73-d058-4ca3-9013-691aae8426fb	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	9922ce14-b418-4235-9c59-d674a8e70210	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	38c838a4-9943-445a-8e80-e823d56eeaa5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	fda413e7-b1ae-312a-e053-6394a90ab2c6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc.	2b9f696a-b637-4dea-e063-6394a90aeb2e	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87df4e-2c97-e23e-e053-2a95a90ab354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	b2db3979-daa6-6e83-e053-2a95a90a3a2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c859c752-8a85-2017-e053-2a95a90a771f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	3ba3c29f-3835-4f4f-a39f-56fb42686f5b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	American Health Packaging	eb850154-4b4b-4d9a-8476-aea1a93fe8d7	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aurobindo Pharma Limited	ea2067bd-1622-4d98-8012-2c09405aa88d	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NorthStar Rx LLC	51c9a29c-a285-40d0-bf3a-7e8c944ee39c	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	67cc924a-26e0-431f-9160-32c9d92a46cd	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WY6W63843K	ZOLPIDEM TARTRATE	99294-93-6	ZOLPIDEM TARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-526-10	63739052610	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-526-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2007-05-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2023-12-14	HUMAN PRESCRIPTION DRUG LABEL	11