Label: BETAMETHASONE DIPROPIONATE cream

  • NDC Code(s): 70771-1380-1, 70771-1380-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

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  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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 - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1380) , MANUFACTURE(70771-1380)