Zolpidem Tartrate

Product NDC: 67296-1591
11-digit product format: 672961591
Labeler code: 67296
Product ID: 67296-1591_d61c28e6-9c53-12db-e053-2a95a90a4e97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA076410
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule: CIV
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	67296-1591		I	Inactivated by FDA		2026-08-03
excluded package	package	67296-1591	67296-1591-6	I	Inactivated by FDA		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	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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`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	67296-1591-6	`1332a3947898…`	`d4bfe170f9cd…`

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
A076410-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL			2007-04-23
A076410-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL			2007-04-23

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	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076410-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076410-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A076410-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076410-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076410-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076410-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076410-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076410-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076410-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076410-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076410-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076410-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076410-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076410-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076410-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076410-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076410-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076410-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076410-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076410-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076410-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076410-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076410-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076410-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076410-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076410-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076410-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076410-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076410-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076410-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076410-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076410-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076410-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076410-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076410-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076410-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076410-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076410-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076410-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076410-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076410-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076410-002	AB	1	`782e0a99824c…`

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
67296-1591-6	2024-01-30	C162847	48780-1	1030e365-66b3-111a-e063-dadaa90a10e2	zolpidem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1591-6	Zolpidem Tartrate	6 in 1 BOTTLE	TABLET, FILM COATED	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1591	ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220122_6a123164-e688-5ce3-e053-2a91aa0a76bc.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e534b3ac-1110-465f-8692-6ea585996fb6	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076410 application number: ANDA076410
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076410 application number: ANDA076410

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	6a123164-e688-5ce3-e053-2a91aa0a76bc	3
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	6a123164-e688-5ce3-e053-2a91aa0a76bc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1591-6	67296159106	6 TABLET, FILM COATED in 1 BOTTLE (67296-1591-6)	2018-01-01	0000-00-00	No	No	Current