Ambien CR

Product NDC: 21695-319
11-digit product format: 216950319
Labeler code: 21695
Product ID: 21695-319_e242ca9c-63bc-44a3-abcf-99632e7703fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA021774
Marketing category: NDA
Marketing start: 2009-06-30
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 6 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-319		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-319	21695-319-30	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 1 · 44 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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`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	21695-319-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-319-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-319-30	`110d247fa046…`	`a55b01930146…`

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
N021774-001	AMBIEN CR	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02
N021774-002	AMBIEN CR	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021774-001	AB
N021774-002	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	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021774-001	AMBIEN CR	12.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2005-09-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021774-002	AMBIEN CR	6.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2005-09-02	`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	N021774-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021774-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021774-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021774-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021774-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021774-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021774-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021774-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021774-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021774-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021774-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021774-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021774-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021774-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021774-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021774-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021774-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021774-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021774-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021774-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021774-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021774-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021774-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021774-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021774-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021774-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021774-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021774-001	6514531	2019-12-01	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	6514531	2019-12-01	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021774-001	6514531	2019-12-01	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-002	6514531	2019-12-01	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021774-001	6514531	2019-12-01	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-002	6514531	2019-12-01	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021774-001	6514531	2019-12-01	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-001	6514531*PED	2020-06-01	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-002	6514531	2019-12-01	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021774-002	6514531*PED	2020-06-01	Pediatric extension	`ea99ee380514…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
21695-319-30	2019-09-24	C162847	48780-1	934fe258-4cd1-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use Ambien CR safely and effectively. See full prescribing information for Ambien CR. Ambien CR ® (zolpidem tartrate extended-release) tablets - CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-319-30	Ambien CR	30 in 1 BOTTLE	TABLET, 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
21695-319-30	EA - Each	21695-319	5e73fd06-57e4-424b-921f-421cf197d13f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
zolpidem	ACTIVE MOIETY	7K383OQI23	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
potassium bitartrate	INACTIVE INGREDIENT	NPT6P8P3UU	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-319	AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20100629_968b5154-3c38-4f20-bbeb-495bcb91cc2b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zolpidem tartrate	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	41124767-8ff7-da5d-e063-6394a90a5203	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Ambien CR	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	2d934da3-bd77-4470-e063-6294a90a64f5	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	39d91478-ea0e-407e-b5cb-0eeb592e0aa4	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	facfc337-3447-4052-a9aa-8aa55282a3e3	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021774 application number: NDA021774

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
854882	AMBIEN CR 12.5 MG Extended Release Oral Tablet	PSN	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854896	AMBIEN CR 6.25 MG Extended Release Oral Tablet	PSN	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	PSN	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	PSN	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854882	zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]	SBD	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854896	zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]	SBD	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854880	zolpidem tartrate 12.5 MG Extended Release Oral Tablet	SCD	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854894	zolpidem tartrate 6.25 MG Extended Release Oral Tablet	SCD	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854882	Ambien CR 12.5 MG Extended Release Oral Tablet	SY	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1
854896	Ambien CR 6.25 MG Extended Release Oral Tablet	SY	968b5154-3c38-4f20-bbeb-495bcb91cc2b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-319-30	21695031930	30 in 1 BOTTLE	Historical