AMMONIUM BROMATUM- ammonium bromatum 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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Ammonium Bromatum 6C 5gAmmonium Bromatum 6C 30gAmmonium Bromatum 6C 100gAmmonium Bromatum 12C 5gAmmonium Bromatum 12C 30gAmmonium Bromatum 12C 100gAmmonium Bromatum 30C 1gAmmonium Bromatum 30C 5gAmmonium Bromatum 30C 30gAmmonium Bromatum 30C 100gAmmonium Bromatum 100C 1gAmmonium Bromatum 100C 5gAmmonium Bromatum 100C 30gAmmonium Bromatum 100C 100gAmmonium Bromatum 200C 1gAmmonium Bromatum 200C 5gAmmonium Bromatum 200C 30gAmmonium Bromatum 200C 100gAmmonium Bromatum 500C 1gAmmonium Bromatum 500C 5gAmmonium Bromatum 500C 30gAmmonium Bromatum 500C 100gAmmonium Bromatum 1M 1gAmmonium Bromatum 1M 5gAmmonium Bromatum 1M 30gAmmonium Bromatum 1M 100gAmmonium Bromatum 10M 1gAmmonium Bromatum 10M 5gAmmonium Bromatum 10M 30gAmmonium Bromatum 10M 100g

AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE1 [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:37662-3606-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3606-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3606-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3606-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE10 [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:37662-3607-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3607-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3607-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3607-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE12 [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:37662-3601-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3601-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3601-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3603
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE100 [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:37662-3603-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3603-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3603-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3603-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3605
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE500 [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:37662-3605-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3605-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3605-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3605-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE6 [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:37662-3600-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3600-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3600-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3602
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE30 [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:37662-3602-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3602-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3602-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3602-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
AMMONIUM BROMATUM 
ammonium bromatum pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-3604
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE200 [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:37662-3604-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
2NDC:37662-3604-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/12/2023
3NDC:37662-3604-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
4NDC:37662-3604-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/12/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-3600, 37662-3601, 37662-3602, 37662-3603, 37662-3604, 37662-3605, 37662-3606, 37662-3607)

Revised: 7/2023
Document Id: 00537772-4bd0-36ee-e063-6294a90a3d66
Set id: 00537772-4bcf-36ee-e063-6294a90a3d66
Version: 1
Effective Time: 20230712
 
Hahnemann Laboratories, INC.