Zolpidem Tartrate

Product NDC: 0955-1703
Requested package NDC: 0955-1703-10
11-digit product format: 009551703
Labeler code: 0955
Product ID: 0955-1703_0e50b7b1-a680-4009-a8d5-d132b5071499
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Sanofi-Aventis U.S. LLC
Application: NDA021774
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-12-06
Marketing end: 2026-05-31
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
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	0955-1703	0955-1703-10	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0955-1703	0955-1703-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0955-1703	0955-1703-10	I	Inactivated by FDA		excluded / ndc_excluded.zip	`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
N021774-001	AMBIEN CR	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02
N021774-002	AMBIEN CR	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021774-001	AB
N021774-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`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	N021774-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021774-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021774-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021774-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021774-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021774-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021774-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021774-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021774-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021774-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021774-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021774-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021774-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021774-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021774-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021774-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021774-001	6514531	2019-12-01	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	6514531	2019-12-01	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021774-001	6514531	2019-12-01	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-002	6514531	2019-12-01	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021774-001	6514531	2019-12-01	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-002	6514531	2019-12-01	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021774-001	6514531	2019-12-01	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-002	6514531	2019-12-01	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0955-1703-10	2024-12-06	C162847	48780-1	1030e364-fd0d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
0955-1703-10	2024-07-30	C162847	48780-1	1030e364-fd0d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
0955-1703-10	2024-01-30	C162847	48780-1	1030e364-fd0d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0955-1703-10	Zolpidem Tartrate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-1703-10	EA - Each	0955-1703	bbaa9993-dc9a-420d-9bdc-f27a411c600e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
zolpidem	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
potassium bitartrate	INACTIVE INGREDIENT	NPT6P8P3UU	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	6
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
zolpidem	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
potassium bitartrate	INACTIVE INGREDIENT	NPT6P8P3UU	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POTASSIUM BITARTRATE	INACTIVE INGREDIENT	NPT6P8P3UU	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0955-1703	ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE [SANOFI-AVENTIS U.S. LLC]	17	Current NDC, Legacy NDC, 1 package rows	20241208_68d4314d-1973-481e-806a-da9f5b4baeb0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zolpidem tartrate	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	41124767-8ff7-da5d-e063-6394a90a5203	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Ambien CR	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	2d934da3-bd77-4470-e063-6294a90a64f5	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	39d91478-ea0e-407e-b5cb-0eeb592e0aa4	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	facfc337-3447-4052-a9aa-8aa55282a3e3	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774

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	facfc337-3447-4052-a9aa-8aa55282a3e3	3
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	facfc337-3447-4052-a9aa-8aa55282a3e3	3
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	PSN	b2c3e941-efa9-4688-b45a-ceb758df717d	1
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	b2c3e941-efa9-4688-b45a-ceb758df717d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0955-1703-10	00955170310	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0955-1703-10)	2010-12-06	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Sanofi-Aventis U.S. LLC \| Sanofi Winthrop Industrie \| Finorga	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	17
Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	4
ZOLPIDIEM TARTRATE ER 12.5mg	DIRECT RX	2022-09-27	HUMAN PRESCRIPTION DRUG LABEL	4
Zolpidem Tartrate	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Zolpidem Tartrate	Preferred Pharmaceuticals Inc.	2019-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
Zolpidem Tartrate	St. Mary's Medical Park Pharmacy \| Sanofi Winthrop Industrie	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	3
Zolpidem Tartrate	NuCare Pharmaceuticals,Inc.	2017-09-12	HUMAN PRESCRIPTION DRUG LABEL	1
Zolpidem Tartrate	Physicians Total Care, Inc.	2010-12-08	HUMAN PRESCRIPTION DRUG LABEL	1