NDC 0115-1704

Dextroamphetamine SulfateExtended-Release Extended-Release

Dextroamphetamine Sulfate

Dextroamphetamine SulfateExtended-Release 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 ID: 0115-1704_059d6473-1cb2-4c13-bde4-ff454eeb5f62
• NDC: 0115-1704
• Product Type: Human Prescription Drug
• Proprietary Name: Dextroamphetamine SulfateExtended-Release Extended-Release
• Generic Name: Dextroamphetamine Sulfate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1976-08-02
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA017078
• Labeler Name: Amneal Pharmaceuticals of New York LLC
• Substance Name: DEXTROAMPHETAMINE SULFATE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0115-1704-10

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1704-10)

• Marketing Start Date: 1976-08-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-1704-10 [00115170410]

Dextroamphetamine SulfateExtended-Release Extended-Release CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA017078
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1976-08-02

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	15 mg/1

OpenFDA Data

• SPL SET ID: 36fa0ccd-33aa-4a22-8441-5f55f8d0870c
• Manufacturer:
  • Impax Generics
• UNII:
  • JJ768O327N
• RxNorm Concept Unique ID - RxCUI:
  • 884535
  • 884532
  • 884520
• UPC Code:
  • 0301151703100
  • 0301151704107
  • 0301151702103

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0406-8958	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate
0406-8959	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate
0406-8960	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0406-8961	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0406-8962	Dextroamphetamine Sulfate	dextroamphetamine sulfate
0555-0952	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0555-0953	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate
0115-1702	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate
0115-1703	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate
0115-1704	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate