NDC 70518-1459

Depakene

Valproic Acid

Depakene is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Valproic Acid.

Product ID70518-1459_776dd690-fe09-00c9-e053-2991aa0ad57c
NDC70518-1459
Product TypeHuman Prescription Drug
Proprietary NameDepakene
Generic NameValproic Acid
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-10-03
Marketing CategoryNDA / NDA
Application NumberNDA018081
Labeler NameREMEDYREPACK INC.
Substance NameVALPROIC ACID
Active Ingredient Strength250 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1459-0

30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (70518-1459-0)
Marketing Start Date2018-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1459-0 [70518145900]

Depakene CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA018081
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-03
Marketing End Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
VALPROIC ACID250 mg/1

OpenFDA Data

SPL SET ID:a0288919-75bf-4752-975f-40579572c0f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099683
  • 1099681

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]

    NDC Crossover Matching brand name "Depakene" or generic name "Valproic Acid"

    NDCBrand NameGeneric Name
    0074-5681DepakeneValproic Acid
    0074-5682DepakeneValproic Acid
    70518-1459DepakeneDepakene
    0591-4012ValproicValproic Acid
    0615-7840ValproicValproic Acid
    0121-0675VALPROIC ACIDVALPROIC ACID
    0121-1350VALPROIC ACIDVALPROIC ACID
    0121-4675VALPROIC ACIDVALPROIC ACID
    0527-5250VALPROIC ACIDVALPROIC ACID
    0527-5407VALPROIC ACIDVALPROIC ACID
    0603-1841Valproic AcidValproic Acid
    0615-1325Valproic AcidValproic Acid
    0615-8205Valproic AcidValproic Acid
    0832-0310valproic acidvalproic acid
    17856-0152Valproic AcidValproic Acid

    Trademark Results [Depakene]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEPAKENE
    DEPAKENE
    72273651 0887024 Live/Registered
    LABORATORIES J. BERTHIER
    1967-06-12
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