NDC 68382-945

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate

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

Product ID68382-945_7a16d81a-a695-478a-9eb1-f09843699173
NDC68382-945
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Sulfate
Generic NameDextroamphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-28
Marketing CategoryANDA / ANDA
Application NumberANDA209111
Labeler NameZydus Pharmaceuticals (USA) 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
Listing Certified Through2022-12-31

Packaging

NDC 68382-945-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-945-01)
Marketing Start Date2017-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-945-01 [68382094501]

Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209111
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-28

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE15 mg/1

OpenFDA Data

SPL SET ID:124c91d5-b533-4caa-aa14-81f1dba9fa90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884535
  • 884532
  • 884520

    • Pharmacological Class

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

    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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