NDC 0406-8962

Dextroamphetamine Sulfate Extended-Release

Dextroamphetamine Sulfate

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

Product ID0406-8962_20dbb7f7-a1db-4b1c-a8d7-15b0c92cea19
NDC0406-8962
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Sulfate Extended-Release
Generic NameDextroamphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-10-07
Marketing CategoryANDA / ANDA
Application NumberANDA076353
Labeler NameSpecGx LLC
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 Through2019-12-31

Packaging

NDC 0406-8962-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8962-01)
Marketing Start Date2003-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-8962-01 [00406896201]

Dextroamphetamine Sulfate Extended-Release CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076353
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-06

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE15 mg/1

OpenFDA Data

SPL SET ID:69c40af8-3710-46bf-bd3d-137fe5eea23e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884535
  • 884532
  • 884520
    • UPC Code
  • 0304068960017
  • 0304068961014
  • 0304068962011

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Dextroamphetamine Sulfate Extended-Release" or generic name "Dextroamphetamine Sulfate"

    NDCBrand NameGeneric Name
    54505-329Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfate Extended-Release
    54505-327Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfate Extended-Release
    54505-328Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfate Extended-Release
    60687-150Dextroamphetamine Sulfate Extended-ReleaseDextroamphetamine Sulfate Extended-Release
    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
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