Buspirone Hydrochloride
BusPIRone HYDROCHLORIDE TABLETS USPRx only
Approved
Approval ID
72bff09c-826e-4394-a7e7-41d56ce9605b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2022
Manufacturers
FDA
NCS HealthCare of KY, LLC dba Vangard Labs
DUNS: 050052943
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buspirone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0615-7714
Application NumberANDA075022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Buspirone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0615-7718
Application NumberANDA075022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Buspirone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0615-7689
Application NumberANDA075022
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB