Buspirone HCL
Buspirone HCL
Approved
Approval ID
3246dd4d-f787-2f62-e063-6294a90a9cd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buspirone HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-620
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone HCL
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/8/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/8/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/8/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/8/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/8/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/8/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 4/8/2025
DRUG ABUSE AND DEPENDENCE SECTION
LOINC: 42227-9Updated: 4/8/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/8/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/8/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/8/2025
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 4/8/2025
REFERENCES SECTION
LOINC: 34093-5Updated: 4/8/2025
PATIENT MEDICATION INFORMATION SECTION
LOINC: 68498-5Updated: 4/8/2025