NDC 0115-9929

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 Amneal Pharmaceuticals Of New York Llc. The primary component is Dextroamphetamine Sulfate.

Product ID0115-9929_5f266881-18bf-44a9-ac0a-78f3278ec5c4
NDC0115-9929
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Sulfate Extended-Release
Generic NameDextroamphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1976-08-02
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA017078
Labeler NameAmneal Pharmaceuticals of New York 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 Through2023-12-31

Packaging

NDC 0115-9929-10

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9929-10)
Marketing Start Date1976-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-9929-10 [00115992910]

Dextroamphetamine Sulfate Extended-Release CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA017078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1976-08-02

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE15 mg/1

OpenFDA Data

SPL SET ID:2ec5c30f-4eb8-48a5-83c4-236450413464
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884535
  • 884532
  • 884520
    • UPC Code
  • 0301159928109
  • 0301159929106
  • 0301159927102

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.