Buspirone HCl
Buspirone HCl Tablets USP Revised: October 2007 Rx only
Approved
Approval ID
0eefdd8d-7745-47ae-a204-f35687f3db11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-217
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2008
FDA Product Classification
INGREDIENTS (6)
Buspirone hydrochlorideActive
Quantity: 10 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
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 Code21695-172
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2008
FDA Product Classification
INGREDIENTS (6)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Buspirone hydrochlorideActive
Quantity: 15 mg in 1 1
Code: 207LT9J9OC
Classification: ACTIB
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 Code21695-256
Application NumberANDA074253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buspirone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2008
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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