NDC 52054-512

DEXEDRINE SPANSULE

Dextroamphetamine Sulfate

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

Product ID52054-512_6e6c242b-da63-4bd3-86a6-f22e10419291
NDC52054-512
Product TypeHuman Prescription Drug
Proprietary NameDEXEDRINE SPANSULE
Generic NameDextroamphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1976-08-02
Marketing End Date2019-12-01
Marketing CategoryNDA / NDA
Application NumberNDA017078
Labeler NameAmedra Pharmaceuticals LLC
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength5 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 52054-512-09

1 BOTTLE in 1 CARTON (52054-512-09) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date1976-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52054-512-09 [52054051209]

DEXEDRINE SPANSULE CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA017078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1976-08-02
Marketing End Date2019-12-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

OpenFDA Data

SPL SET ID:a37b6ef9-78b4-4b18-8797-ecb583502500
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884528
  • 884537
  • 884534
  • 884535
  • 884532
  • 884520
    • UPC Code
  • 0352054513099
  • 0352054514096
  • 0352054512092

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    52054-514DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    52054-513DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    52054-512DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    64896-674DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    64896-673DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    64896-675DEXEDRINE SPANSULEDEXEDRINE SPANSULE
    0115-9927Dextroamphetamine SulfateDextroamphetamine Sulfate
    0115-9928Dextroamphetamine SulfateDextroamphetamine Sulfate
    0115-9929Dextroamphetamine SulfateDextroamphetamine Sulfate
    0406-8958DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfate
    0406-8959DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfate
    0406-8960Dextroamphetamine Sulfatedextroamphetamine sulfate
    0406-8961Dextroamphetamine Sulfatedextroamphetamine sulfate
    0406-8962Dextroamphetamine Sulfatedextroamphetamine sulfate
    0555-0952Dextroamphetamine SulfateDextroamphetamine Sulfate
    0555-0953Dextroamphetamine SulfateDextroamphetamine Sulfate
    0115-1702Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate
    0115-1703Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate
    0115-1704Dextroamphetamine SulfateExtended-ReleaseDextroamphetamine Sulfate

    Trademark Results [DEXEDRINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DEXEDRINE
    DEXEDRINE
    73266838 1177791 Live/Registered
    SMITHKLINE CORPORATION
    1980-06-18
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