0378-4085 : Dexmethylphenidate Hydrochloride 40 mg Oral Capsule, Extended Release


NDC: 0378-4085
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Dexmethylphenidate Hydrochloride
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA204266
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: MYLAN;DE;40
Shapes:  Capsule
Colors:  Gray / White
Size (mm): 25
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:

  • 0378-4085-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4085‑01)
  • 0378-4085-05: 500 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4085‑05)
  • 0378-4085-93: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4085‑93)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Ammonio Methacrylate Copolymer Type B
  • Gelatin
  • Hypromelloses
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Ferrosoferric Oxide
  • Ferric Oxide Yellow
  • Ammonia
  • Propylene Glycol
  • Shellac
  • Sucrose
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-4080 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4081 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4082 Dexmethylphenidate Hydrochloride 15 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4083 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4084 Dexmethylphenidate Hydrochloride 30 mg/1 Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0093-5045 Dexmethylphenidate Hydrochloride 25 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-5046 Dexmethylphenidate Hydrochloride 35 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-5275 Dexmethylphenidate Hydrochloride 2.5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5276 Dexmethylphenidate Hydrochloride 5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5277 Dexmethylphenidate Hydrochloride 10 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5550 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5551 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5552 Dexmethylphenidate Hydrochloride 15 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5553 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5554 Dexmethylphenidate Hydrochloride 30 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0093-5562 Dexmethylphenidate Hydrochloride 40 mg/1 Oral Capsule, Extended Release by Teva Pharmaceuticals USA Inc
  • 0115-1682 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1683 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1684 Dexmethylphenidate Hydrochloride 15 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1685 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Impax Generics
  • More related products ...

NDC 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.