50458-863 : 12 Hr Nucynta 200 mg Extended Release Tablet


NDC50458-863
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Nucynta ER
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.

Appearance:


Markings: OMJ;200
Shapes:  Oval
Colors:  Blue
Size (mm): 21
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:

  • 50458-863-01: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (50458‑863‑01)
  • 50458-863-02: 10 BLISTER PACK IN 1 BOX, UNIT‑DOSE (50458‑863‑02) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

  • Tapentadol Hydrochloride

Dosage Strength:

  • 200 mg

Inactive Ingredients:

  • Polyethylene Glycols
  • Hypromelloses
  • .alpha.-tocopherol
  • Polyvinyl Alcohol
  • Titanium Dioxide
  • Talc
  • Shellac
  • Propylene Glycol
  • Ferrosoferric Oxide
  • Fd&c Blue No. 2
  • Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50458-817 Nucynta 20 mg/ml Oral Solution by Janssen Pharmaceuticals, Inc.
  • 50458-820 Nucynta 50 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-830 Nucynta 75 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-840 Nucynta 100 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-860 12 Hr Nucynta 50 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-861 12 Hr Nucynta 100 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-862 12 Hr Nucynta 150 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-864 12 Hr Nucynta 250 mg Extended Release Tablet by Janssen Pharmaceuticals, Inc.
  • 16590-289 Nucynta 100 mg Oral Tablet by Stat Rx USA
  • 16590-863 Nucynta 50 mg Oral Tablet by Stat Rx USA
  • 16590-889 Nucynta 75 mg Oral Tablet by Stat Rx USA LLC
  • 21695-069 Nucynta 50 mg Oral Tablet by Rebel Distributors Corp
  • 24510-050 Nucynta 50 mg Oral Tablet, Film Coated by Collegium Pharmaceutical, Inc.
  • 24510-075 Nucynta 75 mg Oral Tablet, Film Coated by Collegium Pharmaceutical, Inc.
  • 24510-100 Nucynta 100 mg Oral Tablet, Film Coated by Collegium Pharmaceutical, Inc.
  • 35356-525 Nucynta 50 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-593 Nucynta 75 mg Oral Tablet by Lake Erie Medical Surgical & Supply Dba Quality Care Products LLC
  • 35356-611 Nucynta 100 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-770 12 Hr Nucynta 100 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 35356-810 12 Hr Nucynta 50 mg Extended Release Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 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.