NDC Code(s) : 68071-1657-5
Packager : NuCare Pharmaceuticals,Inc.

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:68071-1657(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:68071-1657-515 g in 1 BOX Type 0: Not a Combination Product07/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078930 09/23/2008

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals, Inc. 010632300 relabel(68071-1657)

PRINCIPAL DISPLAY PANEL

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