Benazepril Hydrochloride
Benazepril Hydrochloride Tablets 5 mg, 10 mg, 20 mg and 40 mg
Approved
Approval ID
56ffd662-60a6-4b43-a7ea-f778714dfbbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-327
Application NumberANDA076402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2009
FDA Product Classification
INGREDIENTS (14)
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
benazepril hydrochlorideActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-612
Application NumberANDA076402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2009
FDA Product Classification
INGREDIENTS (14)
benazepril hydrochlorideActive
Quantity: 5 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-877
Application NumberANDA076402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2009
FDA Product Classification
INGREDIENTS (13)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
benazepril hydrochlorideActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
Benazepril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-326
Application NumberANDA076402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2009
FDA Product Classification
INGREDIENTS (13)
zinc stearateInactive
Code: H92E6QA4FV
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT