Application 090107

Type: ANDA
Sponsor: SANDOZ

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
A090107-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-07-01
A090107-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090107-001	AB
A090107-002	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	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090107-001	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090107-002	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-07-01	`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	A090107-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090107-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090107-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090107-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090107-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090107-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090107-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090107-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090107-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090107-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090107-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090107-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090107-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090107-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090107-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090107-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090107-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090107-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090107-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090107-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090107-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090107-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090107-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090107-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090107-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090107-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090107-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090107-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090107-002	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 · 4 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	82bca7a0-021f-4e35-8b3f-6390eeb863a6	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107 ndc (product): 63629-4708
Zolpidem tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	ce301d8b-0a8c-4404-8697-57222ae17a44	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107 ndc (product): 63629-4597
Zolpidem tartrate	ZOLPIDEM TARTRATE	Sandoz Inc	b1b0085f-d9fe-430a-9bd5-607f607bf7e1	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107 ndc (product): 0781-5316 ndc (product): 0781-5315
Zolpidem tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	25e71199-c55d-4cc6-8388-b309d654d2b0	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090107 application number: ANDA090107 ndc (product): 63187-114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5315	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5315	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5315	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5315	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5316	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5316	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5316	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
0781-5316	Zolpidem tartrate	Zolpidem tartrate	Sandoz Inc	ANDA	Current
45865-956	Zolpidem tartrate	Zolpidem tartrate	medsource pharmaceuticals	ANDA	Current
50090-2895	Zolpidem tartrate	Zolpidem tartrate	A-S Medication Solutions	ANDA	Current
50436-3031	Zolpidem tartrate	Zolpidem tartrate	Unit Dose Services	ANDA	Current
55700-251	Zolpidem tartrate	Zolpidem tartrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-531	Zolpidem tartrate	Zolpidem tartrate	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-812	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	ANDA	Current
61919-955	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	ANDA	Current
63187-114	Zolpidem tartrate	Zolpidem tartrate	Proficient Rx LP	ANDA	Current
63187-114	Zolpidem tartrate	Zolpidem tartrate	Proficient Rx LP	ANDA	Current
63629-4597	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
63629-4597	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
63629-4597	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
63629-4708	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
63629-4708	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
63629-4708	Zolpidem tartrate	Zolpidem tartrate	Bryant Ranch Prepack	ANDA	Current
68788-7903	Zolpidem tartrate	Zolpidem tartrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7903	Zolpidem tartrate	Zolpidem tartrate	Preferred Pharmaceuticals Inc.	ANDA	Current