IGNATIA AMARA- ignatia amara 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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IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED1 [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:37662-1703-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1703-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1703-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1703-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1704
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [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:37662-1704-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1704-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1704-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1704-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED100 [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:37662-1700-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1700-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1700-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1700-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED1 [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:37662-1705-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1697
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [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:37662-1697-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1697-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1697-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1698
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [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:37662-1698-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1698-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1698-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1702
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED500 [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:37662-1702-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1702-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1702-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1702-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1699
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [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:37662-1699-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1699-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1699-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1699-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
IGNATIA AMARA 
ignatia amara pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1701
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [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:37662-1701-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
2NDC:37662-1701-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product10/12/2022
3NDC:37662-1701-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
4NDC:37662-1701-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/12/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1697, 37662-1698, 37662-1699, 37662-1700, 37662-1701, 37662-1702, 37662-1703, 37662-1704, 37662-1705)

Revised: 10/2022
Document Id: eab962ba-6f66-c509-e053-2a95a90a6b44
Set id: eab962ba-6f65-c509-e053-2a95a90a6b44
Version: 1
Effective Time: 20221010
 
Hahnemann Laboratories, INC.