Zolpidem Tartrate

Product NDC: 63629-3548
11-digit product format: 636293548
Labeler code: 63629
Product ID: 63629-3548_7773ba02-33ee-496c-a3a1-3299a5769ad0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078616
Marketing category: ANDA
Marketing start: 2008-11-21
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 10 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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3548		D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-0	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-1	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-2	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-3	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-4	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-5	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-6	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-7	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-8	D	Discontinued by firm	2026-08-07
excluded package	package	63629-3548	63629-3548-9	D	Discontinued by firm	2026-08-07

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 3 · 165 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	63629-3548-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3548-3	`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	63629-3548-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3548-3	`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	63629-3548-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3548-3	`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	63629-3548-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3548-3	`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	63629-3548-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3548-3	`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	63629-3548-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3548-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3548-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3548-6	`cdf11ea48f46…`	`ba0047e9e063…`

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
A078616-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL			2008-11-21
A078616-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL			2008-11-21

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	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2008-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2008-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078616-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL		2008-11-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078616-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL		2008-11-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078616-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078616-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078616-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078616-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078616-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078616-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078616-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078616-002	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3548-0	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-1	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-2	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-3	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-4	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-5	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-6	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-7	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-8	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-9	2021-08-17	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-0	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-1	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-2	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-3	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-4	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-5	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-6	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-7	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-8	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV Initial U.S. Approval: 1992
63629-3548-9	2019-11-27	These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem tartrate tablets Zolpidem tartrate tablets CIV 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
63629-3548-1	EA - Each	63629-3548	72575531-8fc2-488b-abdc-4d0b3a91b670	1	2012-07-24
63629-3548-2	EA - Each	63629-3548	7ca065f1-9e2b-4aa1-810b-3232bdbf7ad6	1	2012-07-24
63629-3548-3	EA - Each	63629-3548	d903f415-8db5-423f-a999-ea42bbbb8617	1	2012-07-24
63629-3548-4	EA - Each	63629-3548	07eaeafd-058b-4261-bd9b-eb760f773e01	1	2012-07-24
63629-3548-5	EA - Each	63629-3548	dbe989a5-28c6-4a74-9c66-7d165057964d	1	2012-07-24
63629-3548-6	EA - Each	63629-3548	560f239f-e0c4-4212-92bc-23c8c92ff69f	1	2012-07-24
63629-3548-7	EA - Each	63629-3548	c442f921-5aec-4c3f-8a8d-46d19f1399fd	1	2012-07-24
63629-3548-8	EA - Each	63629-3548	9482902a-f5eb-4f8c-aef1-d04aa2369073	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ZOLPIDEM TARTRATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WY6W63843K	ZOLPIDEM TARTRATE	99294-93-6	ZOLPIDEM TARTRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Bryant Ranch Prepack \| Vintage Pharmaceuticals-Huntsville	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	2