NDC 47781-174

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

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 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 ID: 47781-174_2a2c90b5-baac-d1de-34ee-4274f6312cd2
• NDC: 47781-174
• Product Type: Human Prescription Drug
• Proprietary Name: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII
• Generic Name: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 Mg,cll
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207388
• Labeler Name: Alvogen Inc.
• Substance Name: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
• Active Ingredient Strength: 1 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: 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]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 47781-174-01

100 TABLET in 1 BOTTLE (47781-174-01)

• Marketing Start Date: 2017-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47781-174-05 [47781017405]

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

• Marketing Category: ANDA
• Application Number: ANDA207388
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28
• Marketing End Date: 2017-07-29

NDC 47781-174-01 [47781017401]

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

• Marketing Category: ANDA
• Application Number: ANDA207388
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28
• Marketing End Date: 2017-07-29

NDC 47781-174-30 [47781017430]

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

• Marketing Category: ANDA
• Application Number: ANDA207388
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28
• Marketing End Date: 2017-07-29

Drug Details

Active Ingredients

Ingredient	Strength
AMPHETAMINE ASPARTATE MONOHYDRATE	1.25 mg/1

OpenFDA Data

• SPL SET ID: c907301d-e24d-9609-5529-fed14f94549f
• Manufacturer:
  • Alvogen Inc.
• UNII:
  • 6DPV8NK46S
  • G83415V073
  • O1ZPV620O4
  • JJ768O327N
• 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, 5 Mg,cll"

NDC	Brand Name	Generic Name
47781-174	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 mg,Cll
47781-175	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 mg,Cll
47781-176	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 mg,Cll
47781-177	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 mg,Cll
47781-178	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll
47781-179	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll
47781-180	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 mg,Cll