Zolpidem Tartrate

Product NDC: 68788-8118
Requested package NDC: 68788-8118-6
11-digit product format: 687888118
Labeler code: 68788
Product ID: 68788-8118_be2188b1-36f4-4ffe-b291-e732d21ac4cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA213592
Marketing category: ANDA
Marketing start: 2021-12-10
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 6 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8118	68788-8118-6	D	Discontinued by firm		2026-08-03

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8118-3	EA - Each	68788-8118	12282d5c-d9c7-4478-8b28-5058a99691d0	1	2022-02-07
68788-8118-6	EA - Each	68788-8118	abc010f1-a3e0-43a5-8cb6-5f96d927d6f7	1	2022-02-07
68788-8118-9	EA - Each	68788-8118	5e78bc12-e130-45a1-80ae-2fb29447f18b	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8118	ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240906_a34198bc-69f9-4dbe-afec-7e99bfe379d1.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8118-6	68788811806	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8118-6)	2021-12-10	0000-00-00	No	No	Current