NDC 43386-870

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate

Dextroamphetamine Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals,inc.. The primary component is Dextroamphetamine Sulfate.

Product ID43386-870_cd8c85d3-dae6-4b72-8b76-554ebb868e4a
NDC43386-870
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Sulfate
Generic NameDextroamphetamine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA204330
Labeler NameLupin Pharmaceuticals,Inc.
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength5 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43386-870-01

100 TABLET in 1 BOTTLE (43386-870-01)
Marketing Start Date2016-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-870-01 [43386087001]

Dextroamphetamine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA204330
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-25

NDC 43386-870-03 [43386087003]

Dextroamphetamine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA204330
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-25

NDC 43386-870-10 [43386087010]

Dextroamphetamine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA204330
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-25

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

OpenFDA Data

SPL SET ID:9aea6b7c-729c-484d-b625-c3591b63b350
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884385
  • 884386
    • UPC Code
  • 0343386870035
  • 0343386871018

    • Pharmacological Class

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

    Medicade Reported Pricing

    43386087001 DEXTROAMPHETAMINE 5 MG TAB

    Pricing Unit: EA | 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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