Zolpidem Tartrate

Product NDC: 68071-3482
11-digit product format: 680713482
Labeler code: 68071
Product ID: 68071-3482_2ad45778-ef3b-9f3e-e063-6394a90a5255
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA078413
Marketing category: ANDA
Marketing start: 2007-05-04
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-3482		D	Discontinued by firm		2026-08-03
excluded package	package	68071-3482	68071-3482-2	D	Discontinued by firm		2026-08-03

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
A078413-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-05-04
A078413-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078413-001	AB
A078413-002	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	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078413-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-05-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078413-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-05-04	`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	A078413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078413-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078413-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078413-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078413-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078413-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078413-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078413-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078413-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078413-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078413-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078413-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078413-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078413-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078413-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078413-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078413-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078413-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078413-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078413-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078413-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078413-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078413-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078413-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078413-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078413-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078413-002	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3482-2	Zolpidem Tartrate	2 in 1 BOTTLE	TABLET, FILM COATED	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3482	ZOLPIDEM TARTRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250105_03207c75-f680-c18a-e063-6294a90afaa1.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 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	91511d2f-7066-49a0-90ea-2940d955c85e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	ef72eb73-d058-4ca3-9013-691aae8426fb	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	9922ce14-b418-4235-9c59-d674a8e70210	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	38c838a4-9943-445a-8e80-e823d56eeaa5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	fda413e7-b1ae-312a-e053-6394a90ab2c6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc.	2b9f696a-b637-4dea-e063-6394a90aeb2e	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87df4e-2c97-e23e-e053-2a95a90ab354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	b2db3979-daa6-6e83-e053-2a95a90a3a2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c859c752-8a85-2017-e053-2a95a90a771f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	3ba3c29f-3835-4f4f-a39f-56fb42686f5b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	American Health Packaging	eb850154-4b4b-4d9a-8476-aea1a93fe8d7	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aurobindo Pharma Limited	ea2067bd-1622-4d98-8012-2c09405aa88d	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NorthStar Rx LLC	51c9a29c-a285-40d0-bf3a-7e8c944ee39c	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	67cc924a-26e0-431f-9160-32c9d92a46cd	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078413 application number: ANDA078413

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	03207c75-f680-c18a-e063-6294a90afaa1	2
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	03207c75-f680-c18a-e063-6294a90afaa1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3482-2	68071348202	2 TABLET, FILM COATED in 1 BOTTLE (68071-3482-2)	2023-08-17	No	No	Historical