AGNUS CASTUS- agnus castus 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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Agnus Castus 6C 5gAgnus Castus 6C 30gAgnus Castus 6C 100gAgnus Castus 12C 5gAgnus Castus 12C 30gAgnus Castus 12C 100gAgnus Castus 30C 1gAgnus Castus 30C 5gAgnus Castus 30C 30gAgnus Castus 30C 100gAgnus Castus 100C 1gAgnus Castus 100C 5gAgnus Castus 100C 30gAgnus Castus 100C 100gAgnus Castus 200C 1gAgnus Castus 200C 5gAgnus Castus 200C 30gAgnus Castus 200C 100gAgnus Castus 500C 1gAgnus Castus 500C 5gAgnus Castus 500C 30gAgnus Castus 500C 100gAgnus Castus 1M 1gAgnus Castus 1M 5gAgnus Castus 1M 30gAgnus Castus 1M 100gAgnus Castus 10M 1gAgnus Castus 10M 5gAgnus Castus 10M 30gAgnus Castus 10M 100g

AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE100 [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:37662-3467-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3467-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3467-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3467-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3464
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE6 [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:37662-3464-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3464-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3464-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3465
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE12 [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:37662-3465-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3465-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3465-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3466
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE30 [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:37662-3466-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3466-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3466-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3466-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3469
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE500 [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:37662-3469-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3469-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3469-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3469-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3470
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE1 [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:37662-3470-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3470-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3470-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3470-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3468
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE200 [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:37662-3468-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3468-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3468-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3468-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
AGNUS CASTUS 
agnus castus pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3471
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE10 [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:37662-3471-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
2NDC:37662-3471-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/28/2023
3NDC:37662-3471-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
4NDC:37662-3471-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/28/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3465, 37662-3464, 37662-3466, 37662-3467, 37662-3468, 37662-3469, 37662-3470, 37662-3471)

Revised: 6/2023
Document Id: ff3f8db9-7589-dfb3-e053-6294a90a0875
Set id: ff3f8db9-7588-dfb3-e053-6294a90a0875
Version: 1
Effective Time: 20230629
 
Hahnemann Laboratories, INC.