Label: DIVALPROEX SODIUM pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 63545-678-01 - Packager: Hahnenmann 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 May 4, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PATIENT MEDICATION INFORMATION
- ACTIVE INGREDIENT
- DOSAGE FORMS & STRENGTHS
- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- WARNINGS
- WARNINGS AND PRECAUTIONS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- INSTRUCTIONS FOR USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- INACTIVE INGREDIENT
- Single label image contains content for sections 1-17.
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INGREDIENTS AND APPEARANCE
DIVALPROEX SODIUM
divalproex sodium pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-678 Route of Administration BUCCAL, SUBLINGUAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI) VALPROIC ACID 30 [hp_C] in 1 [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:63545-678-01 240 [hp_C] in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/04/2017 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/04/2017 Labeler - Hahnenmann Laboratories, Inc. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, Inc. 147098081 manufacture(63545-678)
