DIGITALIS PURPUREA- digitalis purpurea 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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DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0816
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS6 [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:37662-0816-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0816-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0816-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0819
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS100 [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:37662-0819-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0819-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0819-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0819-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0817
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [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:37662-0817-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0817-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0817-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0820
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS200 [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:37662-0820-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0820-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0820-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0820-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0818
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS30 [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:37662-0818-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0818-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0818-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0818-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0823
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [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:37662-0823-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0823-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0823-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0823-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0824
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS1 [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:37662-0824-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0821
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS500 [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:37662-0821-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0821-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0821-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0821-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
DIGITALIS PURPUREA 
digitalis purpurea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-0822
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS1 [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:37662-0822-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
2NDC:37662-0822-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2022
3NDC:37662-0822-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
4NDC:37662-0822-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-0816, 37662-0817, 37662-0818, 37662-0819, 37662-0820, 37662-0821, 37662-0822, 37662-0823, 37662-0824)

Revised: 7/2022
Document Id: e3a004d3-f771-e4e9-e053-2995a90ab43c
Set id: e3a004d3-f770-e4e9-e053-2995a90ab43c
Version: 1
Effective Time: 20220712
 
Hahnemann Laboratories, INC.