ZOLPIDEM TARTRATE

Product NDC: 50090-7557
Requested package NDC: 50090-7557-2
11-digit product format: 500907557
Labeler code: 50090
Product ID: 50090-7557_9d72c803-c640-4334-adb6-ce560f33fa5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078970
Marketing category: ANDA
Marketing start: 2014-04-11
Substance: ZOLPIDEM TARTRATE
Active strength: 12.5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	50090-7557	50090-7557-2	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
A078970-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-09-11
A078970-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078970-001	AB
A078970-002	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 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	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078970-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078970-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078970-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078970-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078970-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078970-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078970-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078970-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078970-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078970-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078970-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078970-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078970-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078970-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078970-002	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7557-2	ZOLPIDEM TARTRATE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7557-2	EA - Each	50090-7557	c22b1d2c-aa00-4219-b9eb-fa2548e59670	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7557	ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	1	Current NDC, 1 package rows	20250529_b96e0270-d3e0-4d24-b575-ec0c130fad2b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	bf99cd5c-9671-45a6-bda9-3dfc8252efdd	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	21767f56-ce92-2b8c-e063-6394a90a8b76	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	bca751bb-5161-5a95-e053-2a95a90aa2dd	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals, Inc.	ac647afe-2fe5-4056-806f-abdd54789b45	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	76ff87e4-3aa2-439d-8436-d9e6affb33c8	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc..	72e19b8e-d13a-4824-aee4-11778eba552c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	028bf425-7a72-464d-a242-aa5deee1ac23	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	30c057fb-2e1b-4b9c-8c8a-79c322151e61	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	c3f23bc3-595b-28e5-e053-2a95a90a9c2c	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	604e77ef-2cda-4efc-abfb-9af549d40fd4	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1a8a8072-39bf-44c5-e063-6294a90a77c3	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	08411424-e8a8-4964-bd04-5b0b5aa5baaf	2024-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	acf9f431-3013-4cfd-ba4d-c4013f20bdab	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970

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	b96e0270-d3e0-4d24-b575-ec0c130fad2b	1
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	b96e0270-d3e0-4d24-b575-ec0c130fad2b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7557-2	50090755702	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7557-2)	2025-05-27	No	No	Historical