Zolpidem Tartrate

Product NDC: 71610-913
Requested package NDC: 71610-913-53
11-digit product format: 716100913
Labeler code: 71610
Product ID: 71610-913_8a13a4cc-3230-4119-9b8c-02fde0298d45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204170
Marketing category: ANDA
Marketing start: 2017-05-15
Substance: ZOLPIDEM TARTRATE
Active strength: 6.25 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 43.

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
A204170-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-01-24
A204170-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204170-001	AB
A204170-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204170-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204170-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204170-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204170-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204170-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204170-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204170-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204170-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204170-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204170-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204170-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204170-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204170-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204170-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204170-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204170-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204170-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204170-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204170-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204170-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204170-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204170-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204170-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204170-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204170-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204170-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	6.25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
a1faca42-6e46-4586-97ac-050b724e7d2a	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	SPL version
71610-913-30	Zolpidem Tartrate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	1
71610-913-53	Zolpidem Tartrate	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	1
71610-913-60	Zolpidem Tartrate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-913-30	EA - Each	71610-913	90fa918c-604b-48eb-ba90-c6defdf9ba09	1	2025-07-08
71610-913-53	EA - Each	71610-913	63f11d8c-dec0-49d1-8da4-1a076763f98b	1	2025-07-08
71610-913-60	EA - Each	71610-913	e6702526-34d8-482c-b325-465334d80403	1	2025-07-08

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 · 6 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	90201886-86a5-4c59-a4f1-98270d620731	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8425be72-2bbe-4090-b00e-610f1a1646b1	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	625fad5b-8817-4773-a2fc-20b662140e6e	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	a1faca42-6e46-4586-97ac-050b724e7d2a	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170 ndc (package): 71610-913-53 ndc (product): 71610-913 ndc11 (package): 71610091353
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Sun Pharmaceutical Industries, Inc.	0c64bc71-2e7f-4b15-a8e1-acb8de04395f	2023-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ebd6c66b-b230-48d7-b38f-d610b6cb2b6c	2019-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204170 application number: ANDA204170

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
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	PSN	a1faca42-6e46-4586-97ac-050b724e7d2a	1
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	SCD	a1faca42-6e46-4586-97ac-050b724e7d2a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-913-53	71610091353	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-913-53)	2025-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	2025-06-09	Human Prescription Drug Label	1