Label: FAMOTIDINE tablet, film coated

  • NDC Code(s): 70771-1702-0, 70771-1702-1, 70771-1702-2, 70771-1702-3, view more
    70771-1702-4, 70771-1702-5, 70771-1703-0, 70771-1703-1, 70771-1703-2, 70771-1703-3, 70771-1703-4, 70771-1703-5
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1702-3

    Famotidine Tablets USP, 20 mg

    30 Tablets

    Rx only

    20 mg label

    NDC 70771-1703-3

    Famotidine Tablets USP, 40 mg

    30 Tablets

    Rx only

    40 mg label
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code Z21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1702-330 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    2NDC:70771-1702-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    3NDC:70771-1702-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    4NDC:70771-1702-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    5NDC:70771-1702-410 in 1 CARTON06/06/2022
    5NDC:70771-1702-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21644106/06/2022
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1703
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code Z41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1703-330 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    2NDC:70771-1703-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    3NDC:70771-1703-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    4NDC:70771-1703-410 in 1 CARTON06/06/2022
    4NDC:70771-1703-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1703-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21644106/06/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1702, 70771-1703) , MANUFACTURE(70771-1702, 70771-1703)