Zolpidem Tartrate

Product NDC: 0054-0087
11-digit product format: 000540087
Labeler code: 0054
Product ID: 0054-0087_84e16e83-b683-4e03-908a-2732c8b59628
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Roxane Laboratories, Inc
Application: ANDA077214
Marketing category: ANDA
Marketing start: 2007-04-27
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: 2019-12-31
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	0054-0087		D	Discontinued by firm		2026-08-03
excluded package	package	0054-0087	0054-0087-29	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0087-29	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0087-29	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0087-29	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0087-29	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0087-29	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0087-29	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0087-29	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0087-29	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0087-29	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0087-29	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0087-29	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0087-29	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A077214-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-04-23
A077214-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077214-001	AB
A077214-002	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	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`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	A077214-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0054-0087-29	2024-02-22	C162847	48780-1	9d75b9d0-a603-f424-e053-dadaa90a57ce	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 administration C-IV Initial U.S. Approval: 1992
0054-0087-29	2020-01-31	C162847	48780-1	9d75b9d0-a603-f424-e053-dadaa90a57ce	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 administration C-IV 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
0054-0087-20	EA - Each	0054-0087	67a22cdd-29ac-41c4-bffb-57220db8a3d1	1	2013-02-11
0054-0087-25	EA - Each	0054-0087	0149c916-bf0b-4336-98bc-902833619621	1	2012-07-24
0054-0087-29	EA - Each	0054-0087	f5383870-c402-40cd-83f5-5758fccb6542	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 [ROXANE LABORATORIES, INC]	9
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ZOLPIDEM TARTRATE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	9

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	3882d72d-686b-406b-e063-6294a90a0b89	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	349053e4-9885-ec0b-e063-6294a90ad79a	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e15d6e3-8d06-0936-e063-6394a90ab8db	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e13ad50-f846-813a-e063-6294a90a5878	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8cef5718-c562-43c3-8abe-a2fc5235ad2a	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	74c4e793-3444-4d3d-8211-26374349ab1e	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	1fa86b79-8809-35f4-e063-6394a90a4377	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	1a8f7696-0d02-dd1f-e063-6394a90a5866	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Roxane Laboratories, Inc \| Boehringer Ingelheim Roxane Inc \| Assia Chemical Industries Ltd. - Teva Tech Site	2013-05-01	HUMAN PRESCRIPTION DRUG LABEL	9