NDC 0378-1072

Dextroamphetamine Sulfate

Dextroamphetamine

Dextroamphetamine Sulfate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Dextroamphetamine Sulfate.

Product ID0378-1072_ab5250ef-0765-4895-b3bd-ebe867ce6382
NDC0378-1072
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Sulfate
Generic NameDextroamphetamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-07-20
Marketing End Date2019-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA206735
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength15 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0378-1072-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-1072-01)
Marketing Start Date2016-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1072-01 [00378107201]

Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-20
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE15 mg/1

OpenFDA Data

SPL SET ID:822ed86d-c311-42fd-834f-d147fdf27b49
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884535
  • 884532
  • 884520
    • UPC Code
  • 0303781071017
  • 2058753012014

    • Pharmacological Class

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

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

    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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