Application 019908

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMBIEN	ZOLPIDEM TARTRATE	TABLET;ORAL	5MG	Yes	No
002	AMBIEN	ZOLPIDEM TARTRATE	TABLET;ORAL	10MG	Yes	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
N019908-001	AMBIEN	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	RLD	1992-12-16
N019908-002	AMBIEN	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019908-001	AB
N019908-002	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	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`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	N019908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019908-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019908-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019908-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019908-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019908-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019908-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019908-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019908-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019908-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019908-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019908-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019908-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019908-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019908-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019908-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ambien	ZOLPIDEM TARTRATE	Sanofi-Aventis U.S. LLC	c36cadf4-65a4-4466-b409-c82020b42452	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019908 application number: NDA019908 ndc (product): 0024-5421 ndc (product): 0024-5401
Ambien	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	747949c5-2c91-4909-8a07-71b6826f8e97	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019908 application number: NDA019908

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0024-5401	Ambien	zolpidem tartrate	Sanofi-Aventis U.S. LLC	NDA	Current
0024-5401	Ambien	zolpidem tartrate	sanofi-aventis U.S. LLC	NDA	Current
0024-5401	Ambien	zolpidem tartrate	sanofi-aventis U.S. LLC	NDA	Current
0024-5401	Ambien	zolpidem tartrate	Sanofi-Aventis U.S. LLC	NDA	Current
0024-5421	Ambien	zolpidem tartrate	Sanofi-Aventis U.S. LLC	NDA	Current
0024-5421	Ambien	zolpidem tartrate	sanofi-aventis U.S. LLC	NDA	Current
0024-5421	Ambien	zolpidem tartrate	sanofi-aventis U.S. LLC	NDA	Current
0024-5421	Ambien	zolpidem tartrate	Sanofi-Aventis U.S. LLC	NDA	Current
21695-211	Ambien	zolpidem tartrate	Rebel Distributors Corp.	NDA	Current
21695-212	Ambien	zolpidem tartrate	Rebel Distributors Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70267	SUPPL	2022-02-25
70266	SUPPL	2022-02-25
70265	SUPPL	2022-02-25
70264	SUPPL	2022-02-25
70245	SUPPL	2022-02-24
70244	SUPPL	2022-02-24
70243	SUPPL	2022-02-24
59776	SUPPL	2019-08-20
59775	SUPPL	2019-08-20
59758	SUPPL	2019-08-20
57598	SUPPL	2019-02-14
57480	SUPPL	2019-02-07
57400	SUPPL	2019-02-01
55739	SUPPL	2018-10-01
55601	SUPPL	2018-09-24
55512	SUPPL	2018-09-18
55500	SUPPL	2018-09-18
48861	SUPPL	2017-06-29
47500	SUPPL	2017-03-08
47473	SUPPL	2017-03-06
46051	SUPPL	2016-12-06
46022	SUPPL	2016-12-05
45043	SUPPL	2016-08-24
45042	SUPPL	2016-08-24
34090	SUPPL	2014-10-09
19833	SUPPL	2014-10-09
20421	SUPPL	2013-09-30
20420	SUPPL	2013-09-30
19832	SUPPL	2013-04-24
19831	SUPPL	2013-04-24
34089	SUPPL	2013-04-23
11841	SUPPL	2013-04-23
34088	SUPPL	2010-04-19
19830	SUPPL	2010-04-19
11840	SUPPL	2008-05-28
1802	SUPPL	2008-05-09
1801	SUPPL	2007-10-22
41092	SUPPL	2007-07-09
19829	SUPPL	2007-04-09
11839	SUPPL	2007-03-31
23560	ORIG	2007-03-16
20419	ORIG	2005-07-13
66832	SUPPL	1900-01-01
52156	SUPPL	1900-01-01
52155	SUPPL	1900-01-01
52154	SUPPL	1900-01-01