Zolpidem Tartrate
Zolpidem Tartrate Tablets 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
Approved
Approval ID
3310d63e-d79a-175d-e063-6394a90a4270
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Advanced Rx of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zolpidem Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0513
Application NumberANDA077322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (13)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/15/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/15/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/15/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/15/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/15/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/15/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/15/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/15/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/15/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/15/2025
DRUG ABUSE AND DEPENDENCE SECTION
LOINC: 42227-9Updated: 4/15/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/15/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/15/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/15/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/15/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/15/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/15/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/15/2025
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 4/15/2025