Application 204170

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	6.25MG	No	No
002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	TABLET, EXTENDED RELEASE;ORAL	12.5MG	No	No

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204170-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204170-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-24	`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	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…`
2022-03-09 01:35 UTC	2022-03	A204170-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204170-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204170-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204170-002	AB	1	`782e0a99824c…`

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 ndc (product): 71335-1468
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
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 ndc (product): 47335-307 ndc (product): 47335-308
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 ndc (product): 71610-254

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-307	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-307	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-307	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-308	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-308	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-308	Zolpidem Tartrate	Zolpidem Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-4479	Zolpidem Tartrate	Zolpidem Tartrate	A-S Medication Solutions	ANDA	Current
55700-573	Zolpidem Tartrate	Zolpidem Tartrate	Lake Erie Medical DBA Qua	ANDA	Current
55700-573	Zolpidem Tartrate	Zolpidem Tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-573	Zolpidem Tartrate	Zolpidem Tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-573	Zolpidem Tartrate	Zolpidem Tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68788-7773	Zolpidem Tartrate	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1468	Zolpidem Tartrate	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
71335-1468	Zolpidem Tartrate	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
71610-254	Zolpidem Tartrate	Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current