0054-0936 : Tapentadol 50 mg Oral Tablet, Film Coated, Extended Release


NDC: 0054-0936
Labeler: Hikma Pharmaceuticals USA Inc.
Product Type: Human Prescription Drug
Drug Name:  Tapentadol
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA200533
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.

NDC Package Codes:

  • 0054-0936-21: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0054‑0936‑21)

Active Ingredients:

  • Tapentadol Hydrochloride

Dosage Strength:

  • 50 mg

Pharmaceutical Classes:

  • Opioid Agonist [EPC]
  • Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0054-0937 Tapentadol 100 mg Oral Tablet, Film Coated, Extended Release by Hikma Pharmaceuticals USA Inc.
  • 0054-0938 Tapentadol 150 mg Oral Tablet, Film Coated, Extended Release by Hikma Pharmaceuticals USA Inc.
  • 0054-0939 Tapentadol 200 mg Oral Tablet, Film Coated, Extended Release by Hikma Pharmaceuticals USA Inc.
  • 0054-0940 Tapentadol 250 mg Oral Tablet, Film Coated, Extended Release by Hikma Pharmaceuticals USA Inc.
  • 0054-0942 Tapentadol 50 mg Oral Tablet, Film Coated by Hikma Pharmaceuticals USA Inc.
  • 0054-0943 Tapentadol 75 mg Oral Tablet, Film Coated by Hikma Pharmaceuticals USA Inc.
  • 0054-0945 Tapentadol 100 mg Oral Tablet, Film Coated by Hikma Pharmaceuticals USA Inc.

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