NDC Code(s) : 63187-433-15
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Betamethasone DipropionateBetamethasone Dipropionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-433(NDC:68462-290)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE DIPROPIONATE(UNII: 826Y60901U)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
CETEARETH-30(UNII: 1R9DCZ5FOX)
CHLOROCRESOL(UNII: 36W53O7109)
CYCLOMETHICONE(UNII: NMQ347994Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITOL(UNII: 506T60A25R)
PETROLATUM(UNII: 4T6H12BN9U)
WHITE WAX(UNII: 7G1J5DA97F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-433-1515 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 ANDA078930 09/23/2008

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079502574 REPACK(63187-433), RELABEL(63187-433)

PRINCIPAL DISPLAY PANEL

NDC 63187-433-15

Betamethasone Dipropionate Cream, 0.05% (Augmented*)
(Potency expressed as betamethasone)
*Vehicle augments the penetration of the steroid.

63187-433-15