Application 078970

Type: ANDA
Sponsor: LUPIN LTD

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
A078970-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-09-11
A078970-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078970-001	AB
A078970-002	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	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078970-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078970-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-09-11	`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	A078970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078970-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078970-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078970-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078970-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078970-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078970-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078970-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078970-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078970-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078970-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078970-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078970-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078970-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078970-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078970-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078970-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078970-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078970-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078970-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078970-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078970-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078970-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078970-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078970-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078970-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078970-002	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 · 13 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	bf99cd5c-9671-45a6-bda9-3dfc8252efdd	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 71335-2085
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	21767f56-ce92-2b8c-e063-6394a90a8b76	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	bca751bb-5161-5a95-e053-2a95a90aa2dd	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 68071-2354
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals, Inc.	ac647afe-2fe5-4056-806f-abdd54789b45	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 68180-780 ndc (product): 68180-779
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	76ff87e4-3aa2-439d-8436-d9e6affb33c8	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc..	72e19b8e-d13a-4824-aee4-11778eba552c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 68788-7422
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	028bf425-7a72-464d-a242-aa5deee1ac23	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	30c057fb-2e1b-4b9c-8c8a-79c322151e61	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	c3f23bc3-595b-28e5-e053-2a95a90a9c2c	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 72189-230
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	604e77ef-2cda-4efc-abfb-9af549d40fd4	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 71335-1180
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1a8a8072-39bf-44c5-e063-6294a90a77c3	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	08411424-e8a8-4964-bd04-5b0b5aa5baaf	2024-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	acf9f431-3013-4cfd-ba4d-c4013f20bdab	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078970 application number: ANDA078970 ndc (product): 71205-286

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-2354	ZOLPIDEM TARTRATE	Zolpidem Tartrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-779	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-779	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-779	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-780	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-780	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-780	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7422	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc..	ANDA	Current
68788-7422	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc..	ANDA	Current
68788-7422	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc..	ANDA	Current
68788-7422	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc..	ANDA	Current
68788-7688	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7688	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-286	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Proficient Rx LP	ANDA	Current
71205-286	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Proficient Rx LP	ANDA	Current
71335-1180	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
71335-1180	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
71335-1180	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
71335-2085	ZOLPIDEM TARTRATE	Zolpidem Tartrate	Bryant Ranch Prepack	ANDA	Current
72189-230	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	ANDA	Current