BISMUTHUM SUBNITRICUM- bismuthum subnitricum 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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BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-492
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE12 [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:63545-492-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-492-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-492-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-494
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE100 [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:63545-494-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-494-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-494-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-494-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-495
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE200 [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:63545-495-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-495-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-495-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-495-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-496
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE500 [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:63545-496-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-496-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-496-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-496-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-491
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE6 [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:63545-491-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-491-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-491-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-493
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE30 [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:63545-493-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-493-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-493-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-493-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-497
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE1 [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:63545-497-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
2NDC:63545-497-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
3NDC:63545-497-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
4NDC:63545-497-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
BISMUTHUM SUBNITRICUM 
bismuthum subnitricum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-498
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE1 [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:63545-498-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(63545-491, 63545-492, 63545-493, 63545-494, 63545-495, 63545-496, 63545-497, 63545-498)

Revised: 5/2022
Document Id: de0f84f3-5f8a-2ac2-e053-2995a90a8caa
Set id: de0f84f3-5f89-2ac2-e053-2995a90a8caa
Version: 1
Effective Time: 20220502
 
Hahnemann Laboratories, INC.