NDC 54092-468

MYDAYIS

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate

MYDAYIS 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 Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

• Product ID: 54092-468_04e5e827-7eae-474a-bbc6-ad34b8479958
• NDC: 54092-468
• Product Type: Human Prescription Drug
• Proprietary Name: MYDAYIS
• Generic Name: Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA022063
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
• Active Ingredient Strength: 3 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 54092-468-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-468-01)

• Marketing Start Date: 2017-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-468-01 [54092046801]

MYDAYIS CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022063
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-20

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	3.125 mg/1

OpenFDA Data

• SPL SET ID: 141a7970-3f06-44ea-9ab7-aeece2c085fc
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 6DPV8NK46S
  • G83415V073
  • O1ZPV620O4
  • JJ768O327N
• RxNorm Concept Unique ID - RxCUI:
  • 1927610
  • 1927617
  • 1927616
  • 1927619
  • 1927630
  • 1927632
  • 1927639
  • 1927637

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

54092046801 MYDAYIS ER 12.5 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "MYDAYIS" or generic name "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate"

NDC	Brand Name	Generic Name
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE