ZOLPIDEM TARTRATE

Product NDC: 45865-413
11-digit product format: 458650413
Labeler code: 45865
Product ID: 45865-413_1b65880c-3eac-4d7f-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA077903
Marketing category: ANDA
Marketing start: 2007-09-05
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-413		I	Inactivated by FDA	2026-08-03
excluded package	package	45865-413	45865-413-30	I	Inactivated by FDA	2026-08-03
excluded package	package	45865-413	45865-413-60	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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-413-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-413-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-413-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-413-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-413-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-413-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-413-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-413-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-413-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-413-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-413-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-413-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-413-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-413-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-413-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-413-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-413-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-413-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A077903-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-08-17
A077903-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077903-001	AB
A077903-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`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	A077903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4	Product name	3	20201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2	Product name	4	20171109
3970acdc-9e18-4f3d-165e-245802aafc57	Product name	2	20160829
438b1497-0992-6caa-062f-3853a7f9e4b1	Product name	1	20140508
813c8976-a1f1-3a35-1a71-1557bfb59446	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-413-30	2025-01-30	C162847	48780-1	2cef2736-766e-d83d-e063-dadaa90ab31f	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 USP, for oral use, C-IV Initial U.S. Approval: 1992
45865-413-60	2025-01-30	C162847	48780-1	2cef2736-766e-d83d-e063-dadaa90ab31f	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 USP, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-413-30	ZOLPIDEM TARTRATE	30 in 1 BOTTLE	TABLET	30		3
45865-413-60	ZOLPIDEM TARTRATE	60 in 1 BOTTLE	TABLET	60		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-413	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3	Legacy NDC, 2 package rows	20150827_1b66047b-4782-4808-e054-00144ff8d46c.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Direct_Rx	907c7b18-2638-512c-e053-2995a90ae6fd	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	26e20f53-c042-eac0-e063-6394a90acfca	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Cardinal Health 107, LLC	83510333-f07d-4b81-a3ae-2801d114bd31	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc.	a9ac3d4e-f502-41e3-95c0-0d334584566d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Major Pharmaceuticals	d34336b1-7041-4078-beda-94bc9d9f771e	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c8adec28-9dcd-4a7e-e053-2a95a90a991e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc76ab4c-3607-39c3-e053-6394a90a6877	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	f939549f-14a6-d37c-e053-6294a90a034a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lake Erie Medical DBA Quality Care Products LLC	db735db9-1c82-4d32-bf91-97b05a75e876	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	95b0ba48-4e71-25f7-e053-2a95a90aea82	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	413b6f65-101e-e2cf-0802-711d080b851b	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903

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	1b66047b-4782-4808-e054-00144ff8d46c	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	1b66047b-4782-4808-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-413-30	45865041330	30 TABLET in 1 BOTTLE (45865-413-30)	30 tablet	2014-02-14	0000-00-00	No	No	Current
45865-413-60	45865041360	60 TABLET in 1 BOTTLE (45865-413-60)	60 tablet	2014-02-14	0000-00-00	No	No	Current