Buspirone Hydrochloride
Approved
Approval ID
f35ec9aa-2be6-40c9-9112-b9e3b80f8fa8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buspirone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4565
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Buspirone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4568
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (6)
BUSPIRONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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
Buspirone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4647
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2011
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