NDC Code(s) : 0093-0840-15, 0093-0840-30, 0093-0840-92
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KetoconazoleKetoconazole CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0840
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE(UNII: R9400W927I)
(KETOCONAZOLE - UNII:R9400W927I) 		KETOCONAZOLE20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
POLYSORBATE 60(UNII: CAL22UVI4M)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM SULFITE(UNII: VTK01UQK3G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-0840-1515 g in 1 TUBE Type 0: Not a Combination Product27/04/2000
2NDC:0093-0840-3030 g in 1 TUBE Type 0: Not a Combination Product27/04/2000
3NDC:0093-0840-9260 g in 1 TUBE Type 0: Not a Combination Product27/04/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075581 04/27/2000 05/31/2017

PRINCIPAL DISPLAY PANEL

Ketoconazole Cream 2% 15 gm Tube