70165-020 : Adzenys Xr-odt 12.5 mg Oral Tablet, Orally Disintegrating

NDC:	70165-020
Labeler:	Neos Therapeutics, Lp
Product Type:	Human Prescription Drug
Drug Name:	Adzenys Xr-odt
Dosage Form:	Oral Tablet, Orally Disintegrating
Application #:	NDA204326
Rev. Date:	Feb 16, 2016
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:	A4
Shapes:	Round
Colors:	Orange
Size (mm):	5
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:

70165-020-30: 30 BLISTER PACK IN 1 CARTON (70165‑020‑30) > 6 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK

Active Ingredients:

Amphetamine

Dosage Strength:

12.5 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]

NDC QR Code

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NDC 70165-020 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.