Zolpidem Tartrate

Product NDC: 43353-617
11-digit product format: 433530617
Labeler code: 43353
Product ID: 43353-617_e3b4f606-6863-49a5-be7c-48d86b85bdaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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: No
Listing certified through: 2019-12-31
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 · 16 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-617		I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-07	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-10	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-14	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-15	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-20	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-21	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-25	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-28	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-30	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-40	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-45	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-53	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-59	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-60	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-617	43353-617-62	I	Inactivated by FDA	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 6 · 336 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	43353-617-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-617-60	`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	43353-617-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-617-60	`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	43353-617-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-617-60	`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	43353-617-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-617-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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…`

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, Related label table
NDC	Related label
43353-617-07	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-10	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-14	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-15	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-20	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-21	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-25	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-28	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-30	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-40	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-45	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-53	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-59	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-60	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, for oral use CIV Initial U.S. Approval: 1992
43353-617-62	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, for oral use CIV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-617-07	Zolpidem Tartrate	7 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	7	2
43353-617-10	Zolpidem Tartrate	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	2
43353-617-14	Zolpidem Tartrate	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	2
43353-617-15	Zolpidem Tartrate	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	2
43353-617-20	Zolpidem Tartrate	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	2
43353-617-21	Zolpidem Tartrate	21 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	21	2
43353-617-25	Zolpidem Tartrate	25 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	25	2
43353-617-28	Zolpidem Tartrate	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28	2
43353-617-30	Zolpidem Tartrate	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
43353-617-40	Zolpidem Tartrate	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	2
43353-617-45	Zolpidem Tartrate	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	2
43353-617-53	Zolpidem Tartrate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2
43353-617-59	Zolpidem Tartrate	22 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	22	2
43353-617-60	Zolpidem Tartrate	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	2
43353-617-62	Zolpidem Tartrate	11 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	11	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-617-07	EA - Each	43353-617	2670f2d5-fbcb-446c-972e-0508a0e4b2bc	1	2013-02-13
43353-617-10	EA - Each	43353-617	f23875b3-c63c-4e16-ae3a-8767d1fc580c	1	2013-02-13
43353-617-14	EA - Each	43353-617	46911ceb-de97-4ef6-befd-b39789024945	1	2013-02-13
43353-617-15	EA - Each	43353-617	50aba351-d27d-4b1e-bfbe-ce5beff552d5	1	2013-02-13
43353-617-20	EA - Each	43353-617	7b456121-b13e-4d3c-899e-c747ad6fec4c	1	2013-02-13
43353-617-21	EA - Each	43353-617	c889b12d-d48e-4582-910a-5cb0ad0337d0	1	2013-04-01
43353-617-25	EA - Each	43353-617	bf0426d6-ad6f-4307-903e-12d0adea6eb6	1	2013-02-13
43353-617-28	EA - Each	43353-617	c15ceff9-6f4c-4a82-88b7-45da03bd9be6	1	2013-02-13
43353-617-30	EA - Each	43353-617	a520954e-8951-49ac-9a7b-bc6c9816c8b6	1	2013-02-13
43353-617-40	EA - Each	43353-617	a645c364-9691-4f54-818a-20aadc88de76	1	2013-02-13
43353-617-45	EA - Each	43353-617	5966b5c5-db2b-445a-a59b-7e7137f0009a	1	2013-02-13
43353-617-53	EA - Each	43353-617	9eba564c-52f3-4adf-9302-b8fd3e0023d4	1	2013-02-13
43353-617-59	EA - Each	43353-617	9a032fe7-cc88-4dd9-8953-987e703055e1	1	2013-02-13
43353-617-60	EA - Each	43353-617	b20a9da0-cedf-4ec5-8ff7-953cb73cd56d	1	2013-02-13
43353-617-62	EA - Each	43353-617	3f08c607-6cf9-4220-8ca3-d5b19a24c7b2	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-617	ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 15 package rows	20140416_cace3d8a-cbb5-4072-9bce-28219b4909ae.zip

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
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	cace3d8a-cbb5-4072-9bce-28219b4909ae	2
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	cace3d8a-cbb5-4072-9bce-28219b4909ae	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	cace3d8a-cbb5-4072-9bce-28219b4909ae	2
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	cace3d8a-cbb5-4072-9bce-28219b4909ae	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-617-07	43353061707	7 in 1 BOTTLE, PLASTIC	Historical
43353-617-10	43353061710	10 in 1 BOTTLE, PLASTIC	Historical
43353-617-14	43353061714	14 in 1 BOTTLE, PLASTIC	Historical
43353-617-15	43353061715	15 in 1 BOTTLE, PLASTIC	Historical
43353-617-20	43353061720	20 in 1 BOTTLE, PLASTIC	Historical
43353-617-21	43353061721	21 in 1 BOTTLE, PLASTIC	Historical
43353-617-25	43353061725	25 in 1 BOTTLE, PLASTIC	Historical
43353-617-28	43353061728	28 in 1 BOTTLE, PLASTIC	Historical
43353-617-30	43353061730	30 in 1 BOTTLE, PLASTIC	Historical
43353-617-40	43353061740	40 in 1 BOTTLE, PLASTIC	Historical
43353-617-45	43353061745	45 in 1 BOTTLE, PLASTIC	Historical
43353-617-53	43353061753	60 in 1 BOTTLE, PLASTIC	Historical
43353-617-59	43353061759	22 in 1 BOTTLE, PLASTIC	Historical
43353-617-60	43353061760	90 in 1 BOTTLE, PLASTIC	Historical
43353-617-62	43353061762	11 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	Aphena Pharma Solutions - Tennessee, LLC	2014-04-10	HUMAN PRESCRIPTION DRUG LABEL	2