Zolpidem Tartrate

Product NDC: 61442-232
11-digit product format: 614420232
Labeler code: 61442
Product ID: 61442-232_14e44cf8-d4c1-5424-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Carlsbad Technology, Inc.
Application: ANDA077990
Marketing category: ANDA
Marketing start: 2007-04-23
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61442-232		D	Discontinued by firm	2026-09-14
excluded package	package	61442-232	61442-232-01	D	Discontinued by firm	2026-09-14
excluded package	package	61442-232	61442-232-05	D	Discontinued by firm	2026-09-14

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 · 45 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	61442-232-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61442-232-05	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	61442-232-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61442-232-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61442-232-05	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61442-232-01	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…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61442-232-05	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61442-232-01	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…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61442-232-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61442-232-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077990-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL			2007-04-23
A077990-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077990-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077990-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`

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	A077990-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077990-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077990-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077990-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077990-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077990-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077990-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077990-002	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61442-232-01	2022-03-24	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 USP, for oral use CIV Initial U.S. Approval: 1992
61442-232-05	2022-03-24	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 USP, for oral use CIV Initial U.S. Approval: 1992
61442-232-01	2020-01-31	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 USP, for oral use CIV Initial U.S. Approval: 1992
61442-232-05	2020-01-31	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 USP, for oral use CIV Initial U.S. Approval: 1992

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET [CARLSBAD TECHNOLOGY, INC.]	8

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	Carlsbad Technology, Inc. \| Yung Shin Pharmaceutical Ind. Co., Ltd.	2015-04-29	HUMAN PRESCRIPTION DRUG LABEL	8