Buspirone hydrochloride
Buspirone Hydrochloride Tablets, USP
Approved
Approval ID
14fd7c1c-778e-46d4-9024-89b319f15f39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 5
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 Code68382-623
Application NumberANDA078888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Buspirone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-181
Application NumberANDA078888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Buspirone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-182
Application NumberANDA078888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code68382-183
Application NumberANDA078888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Buspirone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-180
Application NumberANDA078888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT