Label: BETAMETHASONE DIPROPIONATE ointment

  • NDC Code(s): 70771-1550-1, 70771-1550-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2021

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Betamethasone Dipropionate Ointment USP, 0.05%

    NDC 70771-1550-1 in tube of 15 gm

    Rx Only

    tube label
    carton label
  • INGREDIENTS AND APPEARANCE
    BETAMETHASONE DIPROPIONATE 
    betamethasone dipropionate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1550
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1550-11 in 1 CARTON07/20/2020
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1550-41 in 1 CARTON07/20/2020
    245 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21404807/20/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1550) , MANUFACTURE(70771-1550)