NDC 64896-674

DEXEDRINE SPANSULE

Dextroamphetamine Sulfate

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

Product ID64896-674_08c9d92d-fcca-4c55-bbd4-8bcfb9d0c57f
NDC64896-674
Product TypeHuman Prescription Drug
Proprietary NameDEXEDRINE SPANSULE
Generic NameDextroamphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1976-08-02
Marketing CategoryNDA / NDA
Application NumberNDA017078
Labeler NameAmneal Pharmaceuticals LLC
Substance NameDEXTROAMPHETAMINE SULFATE
Active Ingredient Strength10 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 64896-674-10

1 BOTTLE in 1 CARTON (64896-674-10) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date1976-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64896-674-10 [64896067410]

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

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE10 mg/1

OpenFDA Data

SPL SET ID:cc717b9b-22ea-4c60-a1d4-ee38a40bce78
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884528
  • 884537
  • 884534
  • 884535
  • 884532
  • 884520
    • UPC Code
  • 0364896675101
  • 0364896673107
  • 0364896674104

    • 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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