NDC 58177-312

dextroamphetamine sulfate

Dextroamphetamine Sulfate

dextroamphetamine sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ethex Corporation. The primary component is Dextroamphetamine Sulfate.

Product ID58177-312_1969d6f2-3f37-4317-a73b-09158f83e59c
NDC58177-312
Product TypeHuman Prescription Drug
Proprietary Namedextroamphetamine sulfate
Generic NameDextroamphetamine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA040367
Labeler NameEthex Corporation
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength10 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58177-312-09

1000 TABLET in 1 BOTTLE (58177-312-09)
Marketing Start Date2009-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58177-312-04 [58177031204]

dextroamphetamine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA040367
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-01
Inactivation Date2019-10-21

NDC 58177-312-09 [58177031209]

dextroamphetamine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA040367
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE10 mg/1

OpenFDA Data

SPL SET ID:b2ad8d2b-ed94-43cd-95ea-85e91d997f26
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884385
  • 884386

    • Pharmacological Class

    • 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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