Zolpidem Tartrate

Product NDC: 68788-7182
11-digit product format: 687887182
Labeler code: 68788
Product ID: 68788-7182_8e3d9cc9-eb36-402e-aca4-18770713c652
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: NDA021774
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-07-16
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 13 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: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7182		D	Discontinued by firm	2026-08-03
excluded package	package	68788-7182	68788-7182-2	D	Discontinued by firm	2026-08-03
excluded package	package	68788-7182	68788-7182-3	D	Discontinued by firm	2026-08-03
excluded package	package	68788-7182	68788-7182-6	D	Discontinued by firm	2026-08-03
excluded package	package	68788-7182	68788-7182-9	D	Discontinued by firm	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 · 60 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	68788-7182-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7182-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7182-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7182-9	`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	68788-7182-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7182-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7182-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7182-9	`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	68788-7182-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7182-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7182-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7182-9	`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	68788-7182-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7182-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7182-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7182-9	`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	68788-7182-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7182-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7182-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7182-9	`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	68788-7182-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7182-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7182-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7182-9	`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	68788-7182-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7182-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7182-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7182-9	`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	68788-7182-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7182-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7182-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7182-9	`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	68788-7182-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7182-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7182-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7182-9	`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	68788-7182-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7182-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7182-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7182-9	`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	68788-7182-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7182-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7182-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7182-9	`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	68788-7182-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7182-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7182-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7182-9	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68788-7182-2	2021-02-02	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-3	2021-02-02	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-6	2021-02-02	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-9	2021-02-02	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-2	2021-01-29	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-3	2021-01-29	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-6	2021-01-29	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992
68788-7182-9	2021-01-29	These highlights do not include all the information needed to use Zolpidem Tartrate Extended-Release Tablets safely and effectively. See full prescribing information for Zolpidem Tartrate Extended-Release Tablets. Zolpidem Tartrate Extended-Release Tablets, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7182-2	EA - Each	68788-7182	1984dcfd-6aa9-4d5d-b561-9f5ab72a907c	1	2018-09-05
68788-7182-3	EA - Each	68788-7182	a43204bc-0b4d-45d3-a91a-e567610df766	1	2018-09-05
68788-7182-6	EA - Each	68788-7182	86cf0bfa-d737-4b52-9909-07263db50a1e	1	2018-09-05
68788-7182-9	EA - Each	68788-7182	c61f5b19-907d-4a54-b1c1-57d367bcb3d3	1	2018-09-05

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