DIVALPROEX SODIUM- divalproex sodium 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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Divalproex Sodium 6C 5gDivalproex Sodium 6C 30gDivalproex Sodium 6C 100gDivalproex Sodium 12C 5gDivalproex Sodium 12C 30gDivalproex Sodium 12C 100gDivalproex Sodium 30C 1gDivalproex Sodium 30C 5gDivalproex Sodium 30C 30gDivalproex Sodium 30C 100gDivalproex Sodium 100C 1gDivalproex Sodium 100C 5gDivalproex Sodium 100C 30gDivalproex Sodium 100C 100gDivalproex Sodium 200C 1gDivalproex Sodium 200C 5gDivalproex Sodium 200C 30gDivalproex Sodium 200C 100gDivalproex Sodium 500C 1gDivalproex Sodium 500C 5gDivalproex Sodium 500C 30gDivalproex Sodium 500C 100gDivalproex Sodium 1M 1gDivalproex Sodium 1M 5gDivalproex Sodium 1M 30gDivalproex Sodium 1M 100gDivalproex Sodium 10M 1gDivalproex Sodium 10M 5gDivalproex Sodium 10M 30gDivalproex Sodium 10M 100g

DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2869
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID10 [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:37662-2869-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2869-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2869-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2869-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2862
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID6 [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:37662-2862-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2862-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2862-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2863
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID12 [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:37662-2863-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2863-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2863-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2864
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID30 [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:37662-2864-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2864-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2864-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2864-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2865
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID100 [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:37662-2865-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2865-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2865-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2865-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2866
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID200 [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:37662-2866-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2866-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2866-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2866-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2868
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID1 [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:37662-2868-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2868-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2868-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2868-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
DIVALPROEX SODIUM 
divalproex sodium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-2867
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID500 [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:37662-2867-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
2NDC:37662-2867-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product03/28/2023
3NDC:37662-2867-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
4NDC:37662-2867-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/28/2023
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-2862, 37662-2863, 37662-2864, 37662-2865, 37662-2866, 37662-2867, 37662-2868, 37662-2869)

Revised: 3/2023
Document Id: f7fec516-ec70-6248-e053-6294a90a3342
Set id: f7fec516-ec6f-6248-e053-6294a90a3342
Version: 1
Effective Time: 20230328
 
Hahnemann Laboratories, INC.