NDC 68071-1887-01 - ZOLPIDEM TARTRATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68071-1887
Requested NDC: 68071-1887-01
Package NDCs from labels: 68071-1887-1, 68071-1887-5, 68071-1887-8, 68071-1887-4, 68071-1887-2, 68071-1887-3, 68071-1887-6, 68071-1887-9, 68071-1887-01
Manufacturer: NuCare Pharmaceuticals, Inc | NuCare Pharmaceuticals, Inc.
Effective date: 2024-07-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals, Inc \| NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc \| NuCare Pharmaceuticals, Inc.	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1887-1	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-2	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-3	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-4	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-5	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-6	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-8	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-9	2023-07-03	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-1	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-2	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-3	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-4	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-5	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-6	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-8	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-9	2023-01-30	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-1	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-2	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-3	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-4	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-5	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-6	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-8	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-9	2021-02-10	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-1	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-2	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-3	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-4	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-5	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-6	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-8	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.
68071-1887-9	2021-01-29	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 (USP-CIV) tablets, for oral use Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-1887-1	ZOLPIDEM TARTRATE	10 in 1 BOTTLE	TABLET	10	6
68071-1887-2	ZOLPIDEM TARTRATE	20 in 1 BOTTLE	TABLET	20	6
68071-1887-3	ZOLPIDEM TARTRATE	30 in 1 BOTTLE	TABLET	30	6
68071-1887-4	ZOLPIDEM TARTRATE	14 in 1 BOTTLE	TABLET	14	6
68071-1887-5	ZOLPIDEM TARTRATE	15 in 1 BOTTLE	TABLET	15	6
68071-1887-6	ZOLPIDEM TARTRATE	60 in 1 BOTTLE	TABLET	60	6
68071-1887-8	ZOLPIDEM TARTRATE	28 in 1 BOTTLE	TABLET	28	6
68071-1887-9	ZOLPIDEM TARTRATE	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1887	ZOLPIDEM TARTRATE TABLET [NUCARE PHARMACEUTICALS, INC]	6	Current NDC, Legacy NDC, 8 package rows	20240717_4be6ce23-e7b1-510e-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 9 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	acf9f431-3013-4cfd-ba4d-c4013f20bdab	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	35f6c1ab-a61c-4625-b932-11a7483f1d84	2022-10-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Edluar	ZOLPIDEM TARTRATE	Viatris Specialty LLC	a32884d0-85b5-11de-8a39-0800200c9a66	2022-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem	ZOLPIDEM TARTRATE	Proficient Rx LP	f76eb9d8-ca7d-4479-bd16-52a57f623b02	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	eaca34da-2b12-4dd4-91b5-a8446c7bd41e	2022-07-01	Warnings, Adverse reactions	Exact identifier application number: ANDA077903 rxcui: 854873 unii: WY6W63843K
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	e1f43bde-efba-42be-adef-94e1ef6664fd	2022-04-01	Warnings, Adverse reactions	Exact identifier application number: ANDA077903 rxcui: 854876 unii: WY6W63843K
Zolpidem tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	25e71199-c55d-4cc6-8388-b309d654d2b0	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals,Inc.	6db679f6-b1f8-4fbf-9e87-9cef4650c45a	2020-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	facfc337-3447-4052-a9aa-8aa55282a3e3	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e534b3ac-1110-465f-8692-6ea585996fb6	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ebd6c66b-b230-48d7-b38f-d610b6cb2b6c	2019-03-02	Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873 unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.