54092-474 : Mydayis Oral Capsule, Extended Release


NDC54092-474
Labeler: Shire Us Manufacturing Inc.
Product Type: Human Prescription Drug
Drug Name:  Mydayis
Dosage Form: Oral Capsule, Extended Release
Application #: NDA022063
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: SHIRE;465;37;5mg
Shapes:  Capsule
Colors:  Brown / White
Size (mm): 19
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54092-474-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (54092‑474‑01)

Active Ingredients:

  • Dextroamphetamine Sulfate
  • Dextroamphetamine Saccharate
  • Amphetamine Aspartate Monohydrate
  • Amphetamine Sulfate

Dosage Strength:

  • 9.375 mg
  • 9.375 mg
  • 9.375 mg
  • 9.375 mg

Inactive Ingredients:

  • Gelatin, Unspecified
  • Hypromellose, Unspecified
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Poly(methyl Acrylate-co-methyl Methacrylate-co-methacrylic Acid 7:3:1
  • 280000 Mw)
  • Sucrose
  • Talc
  • Triethyl Citrate
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54092-468 Mydayis Oral Capsule, Extended Release by Shire Us Manufacturing Inc.
  • 54092-471 Mydayis Oral Capsule, Extended Release by Shire Us Manufacturing Inc.
  • 54092-477 Mydayis Oral Capsule, Extended Release by Shire Us Manufacturing Inc.

NDC QR Code

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