BADIAGA- badiaga 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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BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS12 [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:63545-346-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-346-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-346-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-348
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS100 [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:63545-348-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-348-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-348-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
4NDC:63545-348-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS200 [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:63545-349-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-349-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-349-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
4NDC:63545-349-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS500 [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:63545-350-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-350-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-350-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
4NDC:63545-350-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS1 [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:63545-351-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-351-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-351-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
4NDC:63545-351-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS6 [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:63545-345-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-345-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-345-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
BADIAGA 
badiaga pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) (SPONGILLA LACUSTRIS - UNII:6SZ0G98BHM) SPONGILLA LACUSTRIS30 [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:63545-347-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
2NDC:63545-347-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
3NDC:63545-347-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/18/2021
4NDC:63545-347-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/18/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-345, 63545-346, 63545-347, 63545-348, 63545-349, 63545-350, 63545-351)

Revised: 6/2021
Document Id: c50e45f6-6d8c-7582-e053-2a95a90a951d
Set id: c50e45f6-6d8b-7582-e053-2a95a90a951d
Version: 1
Effective Time: 20210618
 
Hahnemann Laboratories, Inc.