NUPHAR LUTEUM- nuphar luteum 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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NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1188
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT200 [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:37662-1188-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1188-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1188-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
4NDC:37662-1188-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT30 [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:37662-1186-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1186-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1186-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
4NDC:37662-1186-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1189
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT500 [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:37662-1189-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1189-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1189-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
4NDC:37662-1189-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT1 [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:37662-1190-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1190-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1190-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
4NDC:37662-1190-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1187
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT100 [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:37662-1187-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1187-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1187-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
4NDC:37662-1187-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT12 [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:37662-1185-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1185-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1185-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1191
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT1 [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:37662-1191-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
NUPHAR LUTEUM 
nuphar luteum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUPHAR LUTEUM ROOT (UNII: 714LIU3V6D) (NUPHAR LUTEUM ROOT - UNII:714LIU3V6D) NUPHAR LUTEUM ROOT6 [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:37662-1184-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/03/2022
2NDC:37662-1184-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
3NDC:37662-1184-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1184, 37662-1185, 37662-1186, 37662-1187, 37662-1188, 37662-1189, 37662-1190, 37662-1191)

Revised: 8/2022
Document Id: e5607f2a-28af-a442-e053-2995a90a01a3
Set id: e5607f2a-28ae-a442-e053-2995a90a01a3
Version: 1
Effective Time: 20220803
 
Hahnemann Laboratories, INC.