NDC 55700-555

Nucynta ER

Tapentadol Hydrochloride

Nucynta ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Qua. The primary component is Tapentadol Hydr.

Product ID55700-555_65acd82a-a85a-4e95-8652-3f287c3436f1
NDC55700-555
Product TypeHuman Prescription Drug
Proprietary NameNucynta ER
Generic NameTapentadol Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-16
Marketing CategoryNDA / NDA
Application NumberNDA200533
Labeler NameLAKE ERIE MEDICAL DBA QUA
Substance NameTAPENTADOL HYDR
Active Ingredient Strength100 mg/1
Pharm ClassesOpioid Agonist
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-555-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-555-60)
Marketing Start Date2017-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-555-60 [55700055560]

Nucynta ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA200533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-06

Drug Details

Active Ingredients

IngredientStrength
TAPENTADOL HYDROCHLORIDE100 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Nucynta ER" or generic name "Tapentadol Hydrochloride"

NDCBrand NameGeneric Name
69865-265Nucynta ERNucynta ER
69865-250Nucynta ERNucynta ER
69865-245Nucynta ERNucynta ER
69865-260Nucynta ERNucynta ER
69865-240Nucynta ERNucynta ER
55700-796Nucynta ERNucynta ER
55700-797Nucynta ERNucynta ER
21695-069NUCYNTAtapentadol hydrochloride
24510-050Nucyntatapentadol hydrochloride
24510-058Nucyntatapentadol hydrochloride
24510-075Nucyntatapentadol hydrochloride
24510-100Nucyntatapentadol hydrochloride
24510-116Nucyntatapentadol hydrochloride
24510-174Nucyntatapentadol hydrochloride
24510-232Nucyntatapentadol hydrochloride
24510-291Nucyntatapentadol hydrochloride
35356-525NucyntaTapentadol hydrochloride
35356-593NUCYNTAtapentadol hydrochloride
35356-611NUCYNTAtapentadol hydrochloride
50458-820NUCYNTAtapentadol hydrochloride
50458-830NUCYNTAtapentadol hydrochloride
50458-840NUCYNTAtapentadol hydrochloride
50458-860Nucyntatapentadol hydrochloride
50458-861Nucyntatapentadol hydrochloride
50458-862Nucyntatapentadol hydrochloride
50458-863Nucyntatapentadol hydrochloride
50458-864Nucyntatapentadol hydrochloride
55700-555Nucyntatapentadol hydrochloride
55700-565Nucyntatapentadol hydrochloride
55700-606Nucyntatapentadol hydrochloride

Trademark Results [Nucynta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NUCYNTA
NUCYNTA
87085846 5133557 Live/Registered
Depo NF Sub, LLC
2016-06-28
NUCYNTA
NUCYNTA
87085841 not registered Live/Pending
Depo NF Sub, LLC
2016-06-28
NUCYNTA
NUCYNTA
77620713 3732548 Live/Registered
DEPO NF SUB, LLC
2008-11-24
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