ASTERIAS RUBENS- asterias rubens 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.

----------

Asterias Rubens 6C 5gAsterias Rubens 6C 30gAsterias Rubens 6C 100gAsterias Rubens 12C 5gAsterias Rubens 12C 30gAsterias Rubens 12C 100gAsterias Rubens 30C 1gAsterias Rubens 30C 5gAsterias Rubens 30C 30gAsterias Rubens 30C 100gAsterias Rubens 100C 1gAsterias Rubens 100C 5gAsterias Rubens 100C 30gAsterias Rubens 100C 100gAsterias Rubens 200C 1gAsterias Rubens 200C 5gAsterias Rubens 200C 30gAsterias Rubens 200C 100gAsterias Rubens 500C 1gAsterias Rubens 500C 5gAsterias Rubens 500C 30gAsterias Rubens 500C 100gAsterias Rubens 1M 1gAsterias Rubens 1M 5gAsterias Rubens 1M 30gAsterias Rubens 1M 100gAsterias Rubens 10M 1gAsterias Rubens 10M 5gAsterias Rubens 10M 30gAsterias Rubens 10M 100gAsterias Rubens LM 1 30g

ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-291
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS1 [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:63545-291-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-285
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS100 [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:63545-285-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-285-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-285-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-285-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-288
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS500 [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:63545-288-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-288-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-288-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-288-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-289
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS1 [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:63545-289-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-289-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-289-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-289-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-290
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS10 [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:63545-290-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-290-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-290-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-290-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-287
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS200 [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:63545-287-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-287-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-287-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-287-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-282
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS6 [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:63545-282-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-282-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-282-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-283
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS12 [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:63545-283-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-283-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-283-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
ASTERIAS RUBENS 
asterias rubens pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-284
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS30 [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:63545-284-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
2NDC:63545-284-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
3NDC:63545-284-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/09/2021
4NDC:63545-284-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2021
Labeler - Hahnemann Laboratories, Inc. (147098081)
Registrant - Hahnemann Laboratories, Inc. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, Inc.147098081manufacture(63545-282, 63545-283, 63545-284, 63545-285, 63545-287, 63545-288, 63545-289, 63545-290, 63545-291)

Revised: 4/2021
Document Id: bf8eac85-9e9a-8ba8-e053-2995a90aa69e
Set id: bf8eac85-9e99-8ba8-e053-2995a90aa69e
Version: 1
Effective Time: 20210409
 
Hahnemann Laboratories, Inc.