Buspirone Hydrochloride
Buspirone Hydrochloride Tablets, USP Rx Only
Approved
Approval ID
a6bdf140-075e-445e-a62d-633a4b97f3a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
Products 6
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 Code29300-247
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code29300-246
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code29300-477
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code29300-245
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code29300-478
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
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 Code29300-244
Application NumberANDA210907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUSPIRONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB