Label: BIOTITUM pellet

  • NDC Code(s): 63545-630-01, 63545-630-02, 63545-630-03, 63545-631-01, view more
    63545-631-02, 63545-631-03, 63545-632-01, 63545-632-02, 63545-632-03, 63545-632-04, 63545-633-01, 63545-633-02, 63545-633-03, 63545-633-04, 63545-634-01, 63545-634-02, 63545-634-03, 63545-634-04, 63545-635-01, 63545-635-02, 63545-635-03, 63545-635-04, 63545-636-01, 63545-636-02, 63545-636-03, 63545-636-04, 63545-638-01
  • Packager: Hahnemann Laboratories, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 9, 2022

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

  • ACTIVE INGREDIENT

  • DOSAGE FORMS & STRENGTHS

  • ACTIVE INGREDIENT

  • PURPOSE

  • INDICATIONS & USAGE

  • WARNINGS

  • PREGNANCY OR BREAST FEEDING

  • ASK DOCTOR

  • KEEP OUT OF REACH OF CHILDREN

  • INSTRUCTIONS FOR USE

  • DOSAGE & ADMINISTRATION

  • ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

  • INACTIVE INGREDIENT

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    Biotitum 6C 5gBiotitum 6C 30gBiotitum 6C 100gBiotitum 12C 5gBiotitum 12C 30gBiotitum 12C 100gBiotitum 30C 1gBiotitum 30C 5gBiotitum 30C 30gBiotitum 30C 100gBiotitum 100C 1gBiotitum 100C 5gBiotitum 100C 30gBiotitum 100C 100gBiotitum 200C 1gBiotitum 200C 5gBiotitum 200C 30gBiotitum 200C 100gBiotitum 500C 1gBiotitum 500C 5gBiotitum 500C 30gBiotitum 500C 100gBiotitum 1M 1gBiotitum 1M 5gBiotitum 1M 30gBiotitum 1M 100gBiotitum LM1 30g

  • INGREDIENTS AND APPEARANCE
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-632-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-632-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-632-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    4NDC:63545-632-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-631
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-631-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-631-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-631-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-630
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-630-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-630-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-630-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-636
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN1 [hp_M]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-636-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-636-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-636-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    4NDC:63545-636-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-633
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN100 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-633-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-633-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-633-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    4NDC:63545-633-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-634
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-634-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-634-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-634-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    4NDC:63545-634-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-635
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN500 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-635-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    2NDC:63545-635-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/09/2022
    3NDC:63545-635-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    4NDC:63545-635-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    BIOTITUM 
    biotitum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-638
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN1 [hp_Q]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-638-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    Labeler - Hahnemann Laboratories, INC. (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, INC.147098081manufacture(63545-630, 63545-631, 63545-632, 63545-633, 63545-634, 63545-635, 63545-636, 63545-638)