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 6 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Preferred Pharmaceuticals Inc.	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	2025-02-12	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077903 rxcui: 854876 rxcui: 854873 unii: WY6W63843K
Ambien	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	747949c5-2c91-4909-8a07-71b6826f8e97	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 rxcui: 854873 unii: WY6W63843K
Ambien CR	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	2d934da3-bd77-4470-e063-6294a90a64f5	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	38c838a4-9943-445a-8e80-e823d56eeaa5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	fda413e7-b1ae-312a-e053-6394a90ab2c6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Prunus Iron	PRUNUS IRON	Uriel Pharmacy Inc.	091be588-b62e-4919-8e9e-3edb9792d319	2025-01-22	Warnings	Exact identifier unii: 1K09F3G675
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	c3f23bc3-595b-28e5-e053-2a95a90a9c2c	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc.	2b9f696a-b637-4dea-e063-6394a90aeb2e	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Ferrum Silicicum Urtica	FERRUM SILICICUM URTICA	Uriel Pharmacy Inc.	09829ac4-c074-7315-e063-6394a90adf59	2025-01-07	Warnings	Exact identifier unii: 1K09F3G675
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 number: ANDA077903 rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87b722-cdb7-0b17-e053-2a95a90a315b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87df4e-2c97-e23e-e053-2a95a90ab354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	b2db3979-daa6-6e83-e053-2a95a90a3a2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K
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 number: ANDA077903 rxcui: 854876 unii: WY6W63843K
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 rxcui: 854873 unii: WY6W63843K
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 number: ANDA077903 rxcui: 854873 unii: WY6W63843K
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 number: ANDA077903 rxcui: 854876 unii: WY6W63843K
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 number: ANDA077903 rxcui: 854873 unii: WY6W63843K
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	3ba3c29f-3835-4f4f-a39f-56fb42686f5b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 854876 unii: WY6W63843K

Reported adverse events (FAERS/openFDA)#

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