Ambien

Product NDC: 21695-211
11-digit product format: 216950211
Labeler code: 21695
Product ID: 21695-211_c298d925-bf40-442d-9041-dea5c50fb60b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA019908
Marketing category: NDA
Marketing start: 2009-06-30
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-211		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-211	21695-211-15	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-211	21695-211-30	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-211-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-211-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-211-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-211-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-211-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-211-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-211-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-211-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-211-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-211-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-211-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-211-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-211-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-211-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-211-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-211-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-211-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-211-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-211-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-211-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-211-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-211-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-211-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-211-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-211-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-211-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-211-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-211-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-211-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-211-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-211-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-211-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-211-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-211-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-211-15	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-211-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-211-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-211-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-211-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-211-30	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-211-15	2019-09-24	C162847	48780-1	934fe258-477c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
21695-211-30	2019-09-24	C162847	48780-1	934fe258-477c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-211-15	Ambien	15 in 1 BOTTLE	TABLET, FILM COATED	15		1
21695-211-30	Ambien	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-211-15	EA - Each	21695-211	b6ff5c89-25eb-4b6b-a212-a660a7b611dc	1	2012-07-24
21695-211-30	EA - Each	21695-211	57a4fb70-ca36-48ec-b801-c5aac3bacfe9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
zolpidem	ACTIVE MOIETY	7K383OQI23	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-211	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 2 package rows	20100629_9dea009e-d435-4268-ab25-cf48a6c69abb.zip

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
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

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
854875	AMBIEN 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	AMBIEN 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	zolpidem tartrate 10 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	zolpidem tartrate 5 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	Ambien 10 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	Ambien 5 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-211-15	21695021115	15 in 1 BOTTLE	Historical
21695-211-30	21695021130	30 in 1 BOTTLE	Historical