NDC 43353-279

Valproic Acid

Valproic Acid

Valproic Acid 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 ID43353-279_1f5efbea-ccd0-4213-9324-769b0077144f
NDC43353-279
Product TypeHuman Prescription Drug
Proprietary NameValproic Acid
Generic NameValproic Acid
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA073484
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 43353-279-53

60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53)
Marketing Start Date2017-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-279-90 [43353027990]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-25

NDC 43353-279-80 [43353027980]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-11

NDC 43353-279-53 [43353027953]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-11

NDC 43353-279-60 [43353027960]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-11

NDC 43353-279-70 [43353027970]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-16

NDC 43353-279-94 [43353027994]

Valproic Acid CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA073484
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-07

Drug Details

Active Ingredients

IngredientStrength
VALPROIC ACID250 mg/1

OpenFDA Data

SPL SET ID:3798f957-8b32-4ac0-8fd1-80283414c255
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 Acid" or generic name "Valproic Acid"

    NDCBrand NameGeneric Name
    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
    68094-701Valproic AcidValproic Acid
    68094-193Valproic AcidValproic Acid
    69387-107Valproic AcidValproic Acid
    69452-150Valproic AcidValproic Acid
    70518-0079Valproic AcidValproic Acid
    70518-0730valproic acidvalproic acid
    70518-1968VALPROIC ACIDVALPROIC ACID
    17856-0792Valproic AcidValproic Acid
    21695-417VALPROIC ACIDVALPROIC ACID
    43353-279Valproic AcidValproic Acid
    43353-085valproic acidvalproic acid
    50090-3027Valproic AcidValproic Acid
    50383-792Valproic acidValproic acid
    55154-1575Valproic AcidValproic Acid
    55154-9430Valproic AcidValproic Acid
    57664-124VALPROIC ACIDVALPROIC ACID
    60432-621Valproic AcidValproic Acid
    60429-246Valproic AcidValproic Acid
    67046-808Valproic AcidValproic Acid
    67046-807Valproic AcidValproic Acid
    67544-479Valproic AcidValproic Acid
    17856-0675VALPROIC ACIDVALPROIC ACID
    72189-010Valproic AcidValproic Acid
    60687-262Valproic AcidValproic Acid
    0074-5681DepakeneValproic Acid
    0074-5682DepakeneValproic Acid
    0591-4012ValproicValproic Acid
    0615-7840ValproicValproic Acid

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.