NUCYNTA ER Film-coated tablet Ref.[10904] Active ingredients: Tapentadol

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

NUCYNTA ER (tapentadol) is an opioid 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).

Dosage Forms and Strengths

NUCYNTA ER 50 mg, 100 mg, 150 mg, 200 mg and 250 mg extended-release tablets are available in the following colors and prints:

  • 50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side
  • 100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side
  • 150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side
  • 200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and a black print “OMJ 200” on one side
  • 250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and a white print “OMJ 250” on one side.
How Supplied

NUCYNTA ER tablets are available in the following strengths and packages:

50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-058-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-058-01).

100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-116-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-116-01).

150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side and are available in bottles of 60 with child-resistant closure (NDC 24510-174-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-174-01).

200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print “OMJ 200” on one side, and are available in bottles of 60 with child- resistant closure (NDC 24510-232-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-232-01).

250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print “OMJ 250” on one side, and are available in bottles of 60 with child-resistant closure (NDC 24510-291-60) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 24510-291-01).

Distributed by: Collegium Pharmaceutical, Inc., Stoughton, MA 02072

U.S. Patent Nos. 6071970, 7994364, 8075872, 8114383, 8309060, 8420056, 8536130, and RE39593.

Drugs

Drug Countries
NUCYNTA Canada, Singapore, United States

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