NDC 43353-085

valproic acid

Valproic Acid

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

Product ID43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e
NDC43353-085
Product TypeHuman Prescription Drug
Proprietary Namevalproic acid
Generic NameValproic Acid
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-10-29
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 43353-085-53

60 CAPSULE in 1 BOTTLE (43353-085-53)
Marketing Start Date2015-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-085-60 [43353008560]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-20

NDC 43353-085-80 [43353008580]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-15

NDC 43353-085-90 [43353008590]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

NDC 43353-085-70 [43353008570]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-16

NDC 43353-085-94 [43353008594]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-28

NDC 43353-085-53 [43353008553]

valproic acid CAPSULE
Marketing CategoryANDA
Application NumberANDA073229
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-20

Drug Details

Active Ingredients

IngredientStrength
VALPROIC ACID250 mg/1

OpenFDA Data

SPL SET ID:3904177b-8a26-4356-9080-d2a2e3f468af
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

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