Zolpidem Tartrate

Product NDC: 76420-496
11-digit product format: 764200496
Labeler code: 76420
Product ID: 76420-496_ea435212-caf8-164b-e053-2a95a90a0bf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA213592
Marketing category: ANDA
Marketing start: 2020-12-17
Substance: ZOLPIDEM TARTRATE
Active strength: 12.5 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: 2026-12-31
Current FDA listing: Yes

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
A213592-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-04
A213592-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213592-001	AB
A213592-002	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 2 · 74 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	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-04	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213592-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213592-002	AB	1	`011fe1cb6892…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213592-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213592-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213592-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213592-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213592-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213592-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213592-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213592-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213592-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213592-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213592-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213592-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213592-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213592-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213592-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213592-002	AB	1	`c0c555d07b60…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213592-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213592-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213592-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213592-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213592-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213592-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213592-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213592-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213592-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213592-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213592-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213592-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213592-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213592-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213592-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213592-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213592-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213592-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zolpidem Tartrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLPIDEM TARTRATE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WY6W63843K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854880	Internal RxNorm lookup
854894	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35f6c1ab-a61c-4625-b932-11a7483f1d84	Available on FDA.report

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-496-01	Zolpidem Tartrate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	1
76420-496-30	Zolpidem Tartrate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
76420-496-60	Zolpidem Tartrate	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	1
76420-496-90	Zolpidem Tartrate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-496-01	EA - Each	76420-496	e7edbd8a-9ec8-425c-a4ea-92efed87f6eb	1	2022-11-07
76420-496-30	EA - Each	76420-496	1ff4bfcf-84c3-4c7c-b59c-f9be3c68a834	1	2022-11-07
76420-496-60	EA - Each	76420-496	0a3e2e2e-d6e7-4cb5-b753-2ded261ebca6	1	2022-11-07
76420-496-90	EA - Each	76420-496	7c9f16ac-6f00-4bd9-8b15-1c333a969277	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-496	ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 4 package rows	20221006_35f6c1ab-a61c-4625-b932-11a7483f1d84.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	Breckenridge Pharmaceutical, Inc.	cbda91f7-4411-4016-80d6-0a349931956d	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213592 application number: ANDA213592
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	35f6c1ab-a61c-4625-b932-11a7483f1d84	2022-10-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213592 application number: ANDA213592 ndc (product): 76420-496

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
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	PSN	35f6c1ab-a61c-4625-b932-11a7483f1d84	1
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	PSN	35f6c1ab-a61c-4625-b932-11a7483f1d84	1
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	35f6c1ab-a61c-4625-b932-11a7483f1d84	1
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	SCD	35f6c1ab-a61c-4625-b932-11a7483f1d84	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-496-01	76420049601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-01)	2022-10-05	0000-00-00	No	No	Current
76420-496-30	76420049630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-30)	2022-10-05	0000-00-00	No	No	Current
76420-496-60	76420049660	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-60)	2022-10-05	0000-00-00	No	No	Current
76420-496-90	76420049690	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-496-90)	2022-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	1