Zolpidem tartrate

Product NDC: 68788-7903
Requested package NDC: 68788-7903-6
11-digit product format: 687887903
Labeler code: 68788
Product ID: 68788-7903_017da303-9b20-46ab-9a39-3894ec141c72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem tartrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA090107
Marketing category: ANDA
Marketing start: 2021-05-14
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	68788-7903	68788-7903-6	D	Discontinued by firm		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 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A090107-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-07-01
A090107-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090107-001	AB
A090107-002	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	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`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	A090107-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090107-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090107-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090107-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090107-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090107-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090107-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090107-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090107-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090107-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090107-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090107-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090107-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090107-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090107-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090107-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090107-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090107-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7903-3	EA - Each	68788-7903	d46234ff-9ead-404f-a2ae-522846359f71	1	2021-07-15
68788-7903-6	EA - Each	68788-7903	5c2255e8-7082-4980-888f-9cc2795eb83f	1	2021-07-15
68788-7903-9	EA - Each	68788-7903	2b8c6fbc-3a60-4a81-a731-17298bad3d8d	1	2021-07-15

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 · 4 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	82bca7a0-021f-4e35-8b3f-6390eeb863a6	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107
Zolpidem tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	ce301d8b-0a8c-4404-8697-57222ae17a44	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107
Zolpidem tartrate	ZOLPIDEM TARTRATE	Sandoz Inc	b1b0085f-d9fe-430a-9bd5-607f607bf7e1	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107
Zolpidem tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	25e71199-c55d-4cc6-8388-b309d654d2b0	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107

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
68788-7903-6	68788790306	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-6)	2021-05-14	0000-00-00	No	No	Current