NDC 54092-391

Adderall XR

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate

Adderall XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Dextroamphetamine Sulfate; Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Amphetamine Sulfate.

Product ID54092-391_05c01190-093d-41b3-8fe6-4ad8d6e2aee3
NDC54092-391
Product TypeHuman Prescription Drug
Proprietary NameAdderall XR
Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2001-10-11
Marketing CategoryNDA / NDA
Application NumberNDA021303
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameDEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
Active Ingredient Strength8 mg/1; mg/1; mg/1; mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54092-391-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-391-01)
Marketing Start Date2002-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-391-01 [54092039101]

Adderall XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021303
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-05-22

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE7.5 mg/1

OpenFDA Data

SPL SET ID:aff45863-ffe1-4d4f-8acf-c7081512a6c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861238
  • 861232
  • 861233
  • 861237
  • 861227
  • 861226
  • 861225
  • 861224
  • 861223
  • 861222
  • 861221
  • 861228
  • UPC Code
  • 0354092383016
  • 0354092385010
  • 0354092387014
  • 0354092391011
  • 0354092381012
  • 0354092389018
  • Pharmacological Class

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

    Medicade Reported Pricing

    54092039101 ADDERALL XR 30 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Adderall XR" or generic name "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate"

    NDCBrand NameGeneric Name
    54092-391Adderall XRAdderall XR
    54092-381AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    54092-383AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    54092-385AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    54092-387AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    54092-389AdderallDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0790Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0791Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0792Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0793Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0794Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
    0527-0795Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

    Trademark Results [Adderall]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADDERALL
    ADDERALL
    74527272 1908092 Live/Registered
    SHIRE LLC
    1994-05-23

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