70165-100 : Cotempla Xr-odt 8.6 mg Oral Tablet, Orally Disintegrating


NDC70165-100
Labeler: Neos Therapeutics, Lp
Product Type: Human Prescription Drug
Drug Name:  Cotempla Xr-odt
Dosage Form: Oral Tablet, Orally Disintegrating
Application #: NDA205489
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: T1
Shapes:  Round
Colors:  Purple
Size (mm): 8
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:

  • 70165-100-30: 5 BLISTER PACK IN 1 CARTON (70165‑100‑30) > 6 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK

Active Ingredients:

  • Methylphenidate

Dosage Strength:

  • 8.6 mg

Inactive Ingredients:

  • Mannitol
  • Fructose
  • Microcrystalline Cellulose
  • Crospovidone, Unspecified
  • Methacrylic Acid
  • Polystyrene Sulfonic Acid
  • Citric Acid Monohydrate
  • Silicon Dioxide
  • Triethyl Citrate
  • Magnesium Stearate
  • Ethylcellulose, Unspecified
  • Sucralose
  • 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.
  • 70165-200 Cotempla Xr-odt 17.3 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp
  • 70165-300 Cotempla Xr-odt 25.9 mg Oral Tablet, Orally Disintegrating by Neos Therapeutics, Lp

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 70165-100 QR Code

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