Zolpidem Tartrate

Product NDC: 67296-0803
11-digit product format: 672960803
Labeler code: 67296
Product ID: 67296-0803_8fa98bad-bdd8-444f-abc6-0b864ea000c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug Inc.
Application: ANDA078616
Marketing category: ANDA
Marketing start: 2008-11-21
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 5 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: E
Listing certified through: 2017-12-31
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	67296-0803		I	Inactivated by FDA		2026-10-20
excluded package	package	67296-0803	67296-0803-1	I	Inactivated by FDA		2026-10-20

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 · 44 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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`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	67296-0803-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0803-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0803-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0803-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0803-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67296-0803-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67296-0803-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67296-0803-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67296-0803-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67296-0803-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67296-0803-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-0803-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078616-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL			2008-11-21
A078616-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL			2008-11-21

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2008-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2008-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2008-11-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2008-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2008-11-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2008-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2008-11-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2008-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078616-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078616-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078616-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078616-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078616-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078616-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078616-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078616-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4	Product name	3	20201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2	Product name	4	20171109
3970acdc-9e18-4f3d-165e-245802aafc57	Product name	2	20160829
438b1497-0992-6caa-062f-3853a7f9e4b1	Product name	1	20140508
813c8976-a1f1-3a35-1a71-1557bfb59446	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0803-1	2019-10-29	C162847	48780-1	960f7f55-da1e-8e05-e053-dbdaa90a074a	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 CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0803-1	Zolpidem Tartrate	10 in 1 BOTTLE	TABLET, FILM COATED	10		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0803	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG INC.]	7	Legacy NDC, 1 package rows	20110603_ff6c0109-e6f3-4920-83f3-6e39fd28a118.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	ff6c0109-e6f3-4920-83f3-6e39fd28a118	7
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	ff6c0109-e6f3-4920-83f3-6e39fd28a118	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67296-0803-1	67296080301	10 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	RedPharm Drug Inc. \| Vintage Pharmaceuticals	2011-05-20	HUMAN PRESCRIPTION DRUG LABEL	7