BIOTITUM- biotitum pellet 
Hahnemann Laboratories, INC.

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.

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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)

Revised: 5/2022
Document Id: de9c9f85-221b-18d2-e053-2a95a90a3c69
Set id: de9c9f85-221a-18d2-e053-2a95a90a3c69
Version: 1
Effective Time: 20220509
 
Hahnemann Laboratories, INC.