NDC 43353-107

Valproic

Valproic Acid

Valproic is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Valproic Acid.

Product ID43353-107_b6b43c41-f63d-4cff-930e-dc9ee7f9201e
NDC43353-107
Product TypeHuman Prescription Drug
Proprietary NameValproic
Generic NameValproic Acid
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2009-09-08
Marketing CategoryANDA / ANDA
Application NumberANDA073229
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 Through2020-12-31

Packaging

NDC 43353-107-53

60 CAPSULE, LIQUID FILLED in 1 BOTTLE (43353-107-53)
Marketing Start Date2016-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-107-70 [43353010770]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-16

NDC 43353-107-60 [43353010760]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-12

NDC 43353-107-94 [43353010794]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-28

NDC 43353-107-80 [43353010780]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-31

NDC 43353-107-90 [43353010790]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-15

NDC 43353-107-53 [43353010753]

Valproic CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
VALPROIC ACID250 mg/1

OpenFDA Data

SPL SET ID:4fc8ffdd-8b79-44de-80d0-6bcc8058f4e1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099681
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0591-4012ValproicValproic Acid
    0615-7840ValproicValproic Acid
    42291-844ValproicValproic
    43353-107ValproicValproic
    63629-7597ValproicValproic
    67046-805ValproicValproic
    67046-806ValproicValproic
    70518-2215ValproicValproic
    17856-4012ValproicValproic
    0074-5681DepakeneValproic Acid
    0074-5682DepakeneValproic 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

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