Ketoconazole
Ketoconazole Cream, 2%
Approved
Approval ID
836ebf14-fb11-45c3-9e0c-db1bebcd0f5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
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.
Ketoconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-556
Application NumberANDA075638
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketoconazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 29, 2010
FDA Product Classification
INGREDIENTS (10)
KetoconazoleActive
Quantity: 20 mg in 1 g
Code: R9400W927I
Classification: ACTIB
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Butylated HydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Ketoconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-554
Application NumberANDA075638
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketoconazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 29, 2010
FDA Product Classification
INGREDIENTS (10)
waterInactive
Code: 059QF0KO0R
Classification: IACT
Butylated HydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
KetoconazoleActive
Quantity: 20 mg in 1 g
Code: R9400W927I
Classification: ACTIB
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Ketoconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-555
Application NumberANDA075638
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketoconazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 29, 2010
FDA Product Classification
INGREDIENTS (10)
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
KetoconazoleActive
Quantity: 20 mg in 1 g
Code: R9400W927I
Classification: ACTIB
Butylated HydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT