NDC 47781-178

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

Product ID47781-178_2a2c90b5-baac-d1de-34ee-4274f6312cd2
NDC47781-178
Product TypeHuman Prescription Drug
Proprietary NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-07-28
Marketing CategoryANDA / ANDA
Application NumberANDA207388
Labeler NameAlvogen Inc.
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active Ingredient Strength4 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 Through2022-12-31

Packaging

NDC 47781-178-01

100 TABLET in 1 BOTTLE (47781-178-01)
Marketing Start Date2017-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-178-30 [47781017830]

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII TABLET
Marketing CategoryANDA
Application NumberANDA207388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Marketing End Date2017-07-29

NDC 47781-178-05 [47781017805]

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII TABLET
Marketing CategoryANDA
Application NumberANDA207388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Marketing End Date2017-07-29

NDC 47781-178-01 [47781017801]

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII TABLET
Marketing CategoryANDA
Application NumberANDA207388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Marketing End Date2017-07-29

Drug Details

Active Ingredients

IngredientStrength
AMPHETAMINE ASPARTATE MONOHYDRATE3.75 mg/1

OpenFDA Data

SPL SET ID:c907301d-e24d-9609-5529-fed14f94549f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 541363
  • 577961
  • 577957
  • 1009145
  • 541878
  • 541892
  • 687043
  • UPC Code
  • 0347781177010
  • 0347781178017
  • 0347781174019
  • 0347781180010
  • 0347781179014
  • 0347781176013
  • 0347781175016
  • 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]

    NDC Crossover Matching brand name "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII" or generic name "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 Mg,cll"

    NDCBrand NameGeneric Name
    47781-174Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 mg,Cll
    47781-175Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 mg,Cll
    47781-176Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 mg,Cll
    47781-177Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 mg,Cll
    47781-178Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll
    47781-179Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll
    47781-180Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CIIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 mg,Cll

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