HURA BRASILIENSIS- hura brasiliensis 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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Hura Brasiliensis 6C 5gHura Brasiliensis 6C 30gHura Brasiliensis 6C 100gHura Brasiliensis 12C 5gHura Brasiliensis 12C 30gHura Brasiliensis 12C 100gHura Brasiliensis 30C 1gHura Brasiliensis 30C 5gHura Brasiliensis 30C 30gHura Brasiliensis 30C 100gHura Brasiliensis 100C 1gHura Brasiliensis 100C 5gHura Brasiliensis 100C 30gHura Brasiliensis 100C 100gHura Brasiliensis 200C 1gHura Brasiliensis 200C 5gHura Brasiliensis 200C 30gHura Brasiliensis 200C 100gHura Brasiliensis 500C 1gHura Brasiliensis 500C 5gHura Brasiliensis 500C 30gHura Brasiliensis 500C 100gHura Brasiliensis 1M 1gHura Brasiliensis 1M 5gHura Brasiliensis 1M 30gHura Brasiliensis 1M 100g

HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP12 [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:37662-2607-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2607-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2607-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP1 [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:37662-2612-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2612-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2612-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
4NDC:37662-2612-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP6 [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:37662-2606-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2606-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2606-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2611
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP500 [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:37662-2611-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2611-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2611-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
4NDC:37662-2611-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2608
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP30 [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:37662-2608-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2608-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2608-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
4NDC:37662-2608-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP100 [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:37662-2609-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2609-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2609-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
4NDC:37662-2609-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
HURA BRASILIENSIS 
hura brasiliensis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HURA CREPITANS SAP (UNII: 8UHN1I06UP) (HURA CREPITANS SAP - UNII:8UHN1I06UP) HURA CREPITANS SAP200 [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:37662-2610-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
2NDC:37662-2610-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2023
3NDC:37662-2610-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
4NDC:37662-2610-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/03/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-2606, 37662-2607, 37662-2608, 37662-2609, 37662-2610, 37662-2611, 37662-2612)

Revised: 2/2023
Document Id: f3d612b0-008c-2bb6-e053-2a95a90a7a9e
Set id: f3d612b0-008b-2bb6-e053-2a95a90a7a9e
Version: 1
Effective Time: 20230203
 
Hahnemann Laboratories, INC.