NDC 76181-002

dextroamphetamine sulfate

Dextroamphetamine Sulfate

dextroamphetamine sulfate is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Avadel Generics, Llc. The primary component is Dextroamphetamine Sulfate.

Product ID76181-002_4d5a136f-e923-4cc6-b92f-1b37d096c875
NDC76181-002
Product TypeHuman Prescription Drug
Proprietary Namedextroamphetamine sulfate
Generic NameDextroamphetamine Sulfate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA040776
Labeler NameAvadel Generics, LLC
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength5 mg/5mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76181-002-25

473 mL in 1 BOTTLE, PLASTIC (76181-002-25)
Marketing Start Date2014-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76181-002-25 [76181000225]

dextroamphetamine sulfate SOLUTION
Marketing CategoryANDA
Application NumberANDA040776
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-01-06
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/5mL

OpenFDA Data

SPL SET ID:f56ea6e8-265a-4e2c-a489-2ad8a50d3157
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884522
    • UPC Code
  • 0376181002257

    • Pharmacological Class

    • Central Nervous System Stimulant [EPC]
    • Central Nervous System Stimulation [PE]

    Medicade Reported Pricing

    76181000225 DEXTROAMPHETAMINE 5 MG/5 ML

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "dextroamphetamine sulfate" or generic name "Dextroamphetamine Sulfate"

    NDCBrand NameGeneric Name
    0115-9927Dextroamphetamine SulfateDextroamphetamine Sulfate
    0115-9928Dextroamphetamine SulfateDextroamphetamine Sulfate
    0115-9929Dextroamphetamine SulfateDextroamphetamine Sulfate
    0378-1070Dextroamphetamine SulfateDextroamphetamine
    0378-1071Dextroamphetamine SulfateDextroamphetamine
    0378-1072Dextroamphetamine SulfateDextroamphetamine
    0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfate
    0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfate
    0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfate
    0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfate
    0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfate
    0555-0952Dextroamphetamine SulfateDextroamphetamine Sulfate
    68382-942DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    68382-944Dextroamphetamine SulfateDextroamphetamine Sulfate
    68382-945Dextroamphetamine SulfateDextroamphetamine Sulfate
    68382-943Dextroamphetamine SulfateDextroamphetamine Sulfate
    68382-941DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    0555-0953Dextroamphetamine SulfateDextroamphetamine Sulfate
    76181-002dextroamphetamine sulfatedextroamphetamine sulfate
    10702-065Dextroamphetamine SulfateDextroamphetamine Sulfate
    10702-066Dextroamphetamine SulfateDextroamphetamine Sulfate
    11534-188DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    11534-189DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
    40032-870Dextroamphetamine SulfateDextroamphetamine Sulfate
    40032-871Dextroamphetamine SulfateDextroamphetamine Sulfate
    43386-870Dextroamphetamine SulfateDextroamphetamine Sulfate
    43386-871Dextroamphetamine SulfateDextroamphetamine Sulfate
    45963-305dextroamphetamine sulfatedextroamphetamine sulfate
    46672-646dextroamphetamine sulfatedextroamphetamine sulfate
    45963-303dextroamphetamine sulfatedextroamphetamine sulfate
    45963-304dextroamphetamine sulfatedextroamphetamine sulfate
    51862-344dextroamphetamine sulfatedextroamphetamine sulfate
    51862-345dextroamphetamine sulfatedextroamphetamine sulfate
    51862-346dextroamphetamine sulfatedextroamphetamine sulfate
    52536-500Dextroamphetamine SulfateDextroamphetamine Sulfate
    52536-510Dextroamphetamine SulfateDextroamphetamine Sulfate
    58177-311dextroamphetamine sulfatedextroamphetamine sulfate
    58177-312dextroamphetamine sulfatedextroamphetamine sulfate
    42543-501dextroamphetamine sulfatedextroamphetamine sulfate
    42543-500dextroamphetamine sulfatedextroamphetamine sulfate
    42543-502dextroamphetamine sulfatedextroamphetamine sulfate
    0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate
    0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate
    0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate
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