NDC 0121-4675

VALPROIC ACID

Valproic Acid

VALPROIC ACID is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Valproic Acid.

Product ID0121-4675_6dd29b7e-3dfb-3bf2-e053-2a91aa0a3e3c
NDC0121-4675
Product TypeHuman Prescription Drug
Proprietary NameVALPROIC ACID
Generic NameValproic Acid
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2005-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA075379
Labeler NamePharmaceutical Associates, Inc.
Substance NameVALPROIC ACID
Active Ingredient Strength250 mg/5mL
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 0121-4675-00

10 TRAY in 1 CASE (0121-4675-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4675-05)
Marketing Start Date2005-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4675-40 [00121467540]

VALPROIC ACID SOLUTION
Marketing CategoryANDA
Application NumberANDA075379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-04-11

NDC 0121-4675-55 [00121467555]

VALPROIC ACID SOLUTION
Marketing CategoryANDA
Application NumberANDA075379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-04
Marketing End Date2017-08-03

NDC 0121-4675-05 [00121467505]

VALPROIC ACID SOLUTION
Marketing CategoryANDA
Application NumberANDA075379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-04-11

NDC 0121-4675-10 [00121467510]

VALPROIC ACID SOLUTION
Marketing CategoryANDA
Application NumberANDA075379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-07-24
Marketing End Date2017-08-03

NDC 0121-4675-00 [00121467500]

VALPROIC ACID SOLUTION
Marketing CategoryANDA
Application NumberANDA075379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-04-11

Drug Details

Active Ingredients

IngredientStrength
VALPROIC ACID250 mg/5mL

OpenFDA Data

SPL SET ID:7d5cb52e-37dd-4dfa-a6f4-09f9548846c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099687
  • Pharmacological Class

    • 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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