70165-005 : Adzenys Xr-odt 3.1 mg Oral Tablet, Orally Disintegrating


NDC70165-005
Labeler: Neos Therapeutics, Lp
Product Type: Human Prescription Drug
Drug Name:  Adzenys Xr-odt
Dosage Form: Oral Tablet, Orally Disintegrating
Application #: NDA204326
Rev. Date: 
CSA Schedule: CII (US) [1]

NDC 70165-005 QR Code


[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: A1
Shapes:  Round
Colors:  Orange
Size (mm): 3
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:

  • 70165-005-30: 30 BLISTER PACK IN 1 CARTON (70165‑005‑30) > 6 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK

Active Ingredients:

  • Amphetamine

Dosage Strength:

  • 3.1 mg

Inactive Ingredients:

  • Mannitol
  • Crospovidone (15 Mpa.s At 5%)
  • Cellulose, Microcrystalline
  • Methacrylic Acid
  • Sodium Polystyrene Sulfonate
  • Citric Acid Monohydrate
  • Fructose
  • Silicon Dioxide
  • Triethyl Citrate
  • Sucralose
  • Magnesium Stearate
  • Polyethylene Glycol, Unspecified

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 70165-010 Adzenys Xr-odt 6.3 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
  • 70165-015 Adzenys Xr-odt 9.4 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
  • 70165-020 Adzenys Xr-odt 12.5 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
  • 70165-025 Adzenys Xr-odt 15.7 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
  • 70165-030 Adzenys Xr-odt 18.8 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
< Prev: 70165-003Next: 70165-010 >

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