zolpidem tartrate

Product NDC: 51407-762
11-digit product format: 514070762
Labeler code: 51407
Product ID: 51407-762_43faa293-f5ec-ef0b-e063-6294a90a755c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: NDA021774
Marketing category: NDA
Marketing start: 2005-09-02
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

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…`

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
41124767-8ff7-da5d-e063-6394a90a5203	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	Strength	SPL version
51407-762-01	zolpidem tartrate	100 in 1 BOTTLE	TABLET, COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-762-01	EA - Each	51407-762	6f714cf2-30e8-44fc-9cdd-1fdcf17b0686	1	2025-11-13

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 ndc (product): 51407-762
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	41124767-8ff7-da5d-e063-6394a90a5203	2
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	PSN	41124767-8ff7-da5d-e063-6394a90a5203	2
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	41124767-8ff7-da5d-e063-6394a90a5203	2
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	SCD	41124767-8ff7-da5d-e063-6394a90a5203	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51407-762-01	51407076201	100 TABLET, COATED in 1 BOTTLE (51407-762-01)	2025-08-26	No	No	Current