ANTIMONIUM OXYDATUM- antimonium oxydatum 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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ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE100 [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:63545-036-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-036-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-036-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
4NDC:63545-036-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE12 [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:63545-034-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-034-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-034-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-037
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE200 [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:63545-037-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-037-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-037-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
4NDC:63545-037-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-039
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE1 [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:63545-039-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-039-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-039-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
4NDC:63545-039-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE6 [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:63545-033-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-033-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-033-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-038
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE500 [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:63545-038-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-038-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-038-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
4NDC:63545-038-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
ANTIMONIUM OXYDATUM 
antimonium oxydatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY TRIOXIDE (UNII: P217481X5E) (ANTIMONY TRIOXIDE - UNII:P217481X5E) ANTIMONY TRIOXIDE30 [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:63545-035-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
2NDC:63545-035-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
3NDC:63545-035-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/09/2021
4NDC:63545-035-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-033, 63545-034, 63545-035, 63545-036, 63545-037, 63545-038, 63545-039)

Revised: 2/2021
Document Id: baeefa41-96f4-3e2d-e053-2a95a90abd55
Set id: baeefa41-96f3-3e2d-e053-2a95a90abd55
Version: 1
Effective Time: 20210209
 
Hahnemann Laboratories, Inc.