69865-245 : Nucynta 100 mg Oral Tablet, Film Coated, Extended Release


NDC: 69865-245
Labeler: Depo Nf Sub, LLC
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;100
Shapes:  Oval
Colors:  Blue
Size (mm): 17
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:

  • 69865-245-01: 10 BLISTER PACK IN 1 CARTON (69865‑245‑01) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK
  • 69865-245-02: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (69865‑245‑02)

Active Ingredients:

  • Tapentadol Hydrochloride

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Polyethylene Glycol, Unspecified
  • Hypromellose, Unspecified
  • .alpha.-tocopherol
  • Polyvinyl Alcohol, Unspecified
  • 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.
  • 69865-240 Nucynta 50 mg Oral Tablet, Film Coated, Extended Release by Depo Nf Sub, LLC
  • 69865-250 Nucynta 150 mg Oral Tablet, Film Coated, Extended Release by Depo Nf Sub, LLC
  • 69865-260 Nucynta 200 mg Oral Tablet, Film Coated, Extended Release by Depo Nf Sub, LLC
  • 69865-265 Nucynta 250 mg Oral Tablet, Film Coated, Extended Release by Depo Nf Sub, LLC
  • 24510-058 Nucynta 50 mg Oral Tablet, Film Coated, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-116 Nucynta 100 mg Oral Tablet, Film Coated, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-174 Nucynta 150 mg Oral Tablet, Film Coated, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-232 Nucynta 200 mg Oral Tablet, Film Coated, Extended Release by Collegium Pharmaceutical, Inc.
  • 24510-291 Nucynta 250 mg Oral Tablet, Film Coated, Extended Release by Collegium Pharmaceutical, Inc.
  • 55700-419 Nucynta 150 mg Oral Tablet, Film Coated, Extended Release by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-555 Nucynta 100 mg Oral Tablet, Film Coated, Extended Release by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-565 Nucynta 50 mg Oral Tablet, Film Coated, Extended Release by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-796 Nucynta 50 mg Oral Tablet, Film Coated, Extended Release by Quality Care Products, LLC
  • 55700-797 Nucynta 100 mg Oral Tablet, Film Coated, Extended Release by Quality Care Products, LLC

NDC QR Code

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NDC 69865-245 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.