Label: DIVALPROEX SODIUM pellet
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NDC Code(s):
37662-2862-1,
37662-2862-2,
37662-2862-3,
37662-2863-1, view more37662-2863-2, 37662-2863-3, 37662-2864-1, 37662-2864-2, 37662-2864-3, 37662-2864-4, 37662-2865-1, 37662-2865-2, 37662-2865-3, 37662-2865-4, 37662-2866-1, 37662-2866-2, 37662-2866-3, 37662-2866-4, 37662-2867-1, 37662-2867-2, 37662-2867-3, 37662-2867-4, 37662-2868-1, 37662-2868-2, 37662-2868-3, 37662-2868-4, 37662-2869-1, 37662-2869-2, 37662-2869-3, 37662-2869-4
- Packager: Hahnemann Laboratories, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE FORMS & STRENGTHS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- DOSAGE & ADMINISTRATION
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2869 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 10 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2869-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2869-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2869-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2869-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2862 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2862-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2862-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2862-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2863 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 12 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2863-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2863-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2863-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2864 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2864-1 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2864-2 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2864-3 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2864-4 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2865 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 100 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2865-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2865-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2865-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2865-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2866 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 200 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2866-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2866-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2866-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2866-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2868 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 1 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2868-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2868-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2868-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2868-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-2867 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 500 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-2867-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 2 NDC:37662-2867-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/28/2023 3 NDC:37662-2867-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 4 NDC:37662-2867-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/28/2023 Labeler - Hahnemann Laboratories, INC. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, INC. 147098081 manufacture(37662-2862, 37662-2863, 37662-2864, 37662-2865, 37662-2866, 37662-2867, 37662-2868, 37662-2869)
