Zolpidem

Product NDC: 68071-2642
11-digit product format: 680712642
Labeler code: 68071
Product ID: 68071-2642_d889c0f8-f19d-0dfa-e053-2995a90a8243
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077214
Marketing category: ANDA
Marketing start: 2020-09-24
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68071-2642		I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2642	68071-2642-3	I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2642	68071-2642-4	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	68071-2642-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2642-3	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	68071-2642-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2642-3	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	68071-2642-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2642-3	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	68071-2642-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2642-3	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	68071-2642-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2642-3	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	68071-2642-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2642-3	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	68071-2642-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2642-4	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	68071-2642-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2642-4	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	68071-2642-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2642-4	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
A077214-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-04-23
A077214-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077214-001	AB
A077214-002	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	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`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	A077214-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	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
68071-2642-3	2025-01-30	C162847	48780-1	2cef2736-9900-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, for oral use, C-IV Initial U.S. Approval: 1992
68071-2642-4	2025-01-30	C162847	48780-1	2cef2736-9900-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, 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
68071-2642-3	Zolpidem	30 in 1 BOTTLE	TABLET	30		1
68071-2642-4	Zolpidem	14 in 1 BOTTLE	TABLET	14		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2642	ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220222_d889c0f8-f19e-0dfa-e053-2995a90a8243.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 · 21 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.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	3882d72d-686b-406b-e063-6294a90a0b89	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	349053e4-9885-ec0b-e063-6294a90ad79a	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e15d6e3-8d06-0936-e063-6394a90ab8db	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e13ad50-f846-813a-e063-6294a90a5878	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8cef5718-c562-43c3-8abe-a2fc5235ad2a	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	74c4e793-3444-4d3d-8211-26374349ab1e	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	1fa86b79-8809-35f4-e063-6394a90a4377	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	1a8f7696-0d02-dd1f-e063-6394a90a5866	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214

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
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	d889c0f8-f19e-0dfa-e053-2995a90a8243	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	d889c0f8-f19e-0dfa-e053-2995a90a8243	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2642-3	68071264203	30 TABLET in 1 BOTTLE (68071-2642-3)	30 tablet	2022-02-21	0000-00-00	No	No	Current
68071-2642-4	68071264204	14 TABLET in 1 BOTTLE (68071-2642-4)	14 tablet	2022-02-21	0000-00-00	No	No	Current