NDC Code(s) : 69238-1532-5, 69238-1532-3, 69238-1532-4, 69238-1532-6
Packager : Amneal Pharmaceuticals NY LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clobetasol PropionateClobetasol Propionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1532
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCOL STEARATE(UNII: 0324G66D0E)
LANOLIN OIL(UNII: OVV5IIJ58F)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 60(UNII: CAL22UVI4M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
POLYOXYL 8 STEARATE(UNII: 2P9L47VI5E)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color white (White to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-1532-51 in 1 CARTON 28/12/2018
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:69238-1532-31 in 1 CARTON 28/12/2018
230 g in 1 TUBE Type 0: Not a Combination Product
3NDC:69238-1532-41 in 1 CARTON 28/12/2018
345 g in 1 TUBE Type 0: Not a Combination Product
4NDC:69238-1532-61 in 1 CARTON 28/12/2018
460 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211256 12/28/2018

LABELER - Amneal Pharmaceuticals NY LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals, LLC 053542455 analysis(69238-1532), label(69238-1532), manufacture(69238-1532), pack(69238-1532)

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PRINCIPAL DISPLAY PANEL

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