Nucynta ER

NUCYNTA® ER (tapentadol) is indicated for the management of:

  • moderate to severe chronic pain in adults
  • neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults

when a continuous, around-the-clock opioid analgesic is needed for an extended period of time [see 14.2)].

Limitations of Usage

NUCYNTA® ER is not intended for use:

  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

Nucynta ER Description

NUCYNTA® ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is:

The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO•HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).

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Active Nucynta ER Ingredients

  1. Tapentadol Hydrochloride

Nucynta ER NDC Codes

NDC Quantity Package
35356-0770-60 60 1 Bottle
50458-0860-01 60 1 Bottle
50458-0860-02 10 1 Box Unit Dose
50458-0861-01 60 1 Bottle
50458-0861-02 10 1 Box Unit Dose
50458-0862-01 60 1 Bottle
50458-0862-02 10 1 Box Unit Dose
50458-0863-01 60 1 Bottle
50458-0863-02 10 1 Box Unit Dose
50458-0864-01 60 1 Bottle
50458-0864-02 10 1 Box Unit Dose
35356-0810-60 60 1 Bottle

Nucynta ER Structured Product Labels

SPL Manufacturer
8aac7e48-f10c-4623-8fb5-1d74d5e22520 Lake Erie Medical DBA Quality Care Products LLC
f4c911f3-484b-44fa-833e-2d970d39be8f Janssen Pharmaceuticals, Inc.
a9a13367-b5f0-4255-ae6a-8f558d90cd07 Lake Erie Medical DBA Quality Care Products LLC

Nucynta ER Overview

Overall Rating
Medication Type
Prescription
Approval Date
Aug 25, 2011
DEA Schedule
Class 2

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