BETAMETHASONE DIPROPIONATE - betamethasone dipropionate cream 
Zydus Lifesciences Limited

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Betamethasone Dipropionate Cream USP, 0.05%
(Potency expressed as betamethasone)
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1380-1

Betamethasone dipropionate cream USP, 0.05%

Rx only

15 g

Betamethazone Dipropionate Cream, USP
Betamethazone Dipropionate Cream, USP
BETAMETHASONE DIPROPIONATE 
betamethasone dipropionate cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1380-11 in 1 CARTON02/26/2019
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70771-1380-41 in 1 CARTON02/26/2019
245 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888502/26/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1380) , MANUFACTURE(70771-1380)

Revised: 8/2022
Document Id: 8bd7a74c-aa74-46e4-9aec-f374ac114646
Set id: bc9ca1f4-8f40-44e1-bb2d-42ecba35d406
Version: 3
Effective Time: 20220803
 
Zydus Lifesciences Limited