tapentadol Extended Release Oral Tablet

Brand(s)
Nucynta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-04-25)
Oldest Current Product
2011-08-25
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\TAPENTADOL
FDAOB
ORAL\TABLET, EXTENDED RELEASE\TAPENTADOL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TAPENTADOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\TAPENTADOL

product(s) by strength(s)

12 hr tapentadol 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580861NucyntaNDAJanssen Pharmaceuticals, Inc.2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200533f4c911f3-484b-44fa-833e-2d970d39be8f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560770NucyntaNDALake Erie Medical Dba Quality Care Products Llc2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE504580861NDA2005338aac7e48-f10c-4623-8fb5-1d74d5e22520

12 hr tapentadol 150 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580862NucyntaNDAJanssen Pharmaceuticals, Inc.2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200533f4c911f3-484b-44fa-833e-2d970d39be8f

12 hr tapentadol 200 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580863NucyntaNDAJanssen Pharmaceuticals, Inc.2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200533f4c911f3-484b-44fa-833e-2d970d39be8f

12 hr tapentadol 250 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580864NucyntaNDAJanssen Pharmaceuticals, Inc.2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200533f4c911f3-484b-44fa-833e-2d970d39be8f

12 hr tapentadol 50 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580860NucyntaNDAJanssen Pharmaceuticals, Inc.2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200533f4c911f3-484b-44fa-833e-2d970d39be8f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560810NucyntaNDALake Erie Medical Dba Quality Care Products Llc2011-08-25TAPENTADOL HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE504580860NDA200533a9a13367-b5f0-4255-ae6a-8f558d90cd07

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200533NUCYNTA ERDEPOMED INC2011-08-25p8075872, SUBSTANCE
p7994364, RELIEF OF MODERATE TO SEVERE CHRONIC PAIN/ MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY, SUBSTANCE
p8114383, SUBSTANCE
p6071970, RELIEF OF MODERATE TO SEVERE CHRONIC PAIN/ MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
pRE39593, RELIEF OF MODERATE TO SEVERE CHRONIC PAIN/ MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY, SUBSTANCE
p8420056, SUBSTANCE
p8536130, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY
p8309060, RELIEF OF MODERATE TO SEVERE CHRONIC PAIN/ MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY, SUBSTANCE
MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) IN ADULTS WHEN A CONTINUOUS [2015-08-28]
NEW DOSAGE FORM [2014-08-25]
NDA200533_001, NDA200533_002, NDA200533_003, NDA200533_004, NDA200533_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200533_001RXTAPENTADOL HYDROCHLORIDE (EQ 50MG BASE)ORALTABLET, EXTENDED RELEASEFalse2011-08-25NUCYNTA ER
2NDA200533_002RXTAPENTADOL HYDROCHLORIDE (EQ 100MG BASE)ORALTABLET, EXTENDED RELEASEFalse2011-08-25NUCYNTA ER
3NDA200533_003RXTAPENTADOL HYDROCHLORIDE (EQ 150MG BASE)ORALTABLET, EXTENDED RELEASEFalse2011-08-25NUCYNTA ER
4NDA200533_004RXTAPENTADOL HYDROCHLORIDE (EQ 200MG BASE)ORALTABLET, EXTENDED RELEASEFalse2011-08-25NUCYNTA ER
5NDA200533_005RXTAPENTADOL HYDROCHLORIDE (EQ 250MG BASE)ORALTABLET, EXTENDED RELEASETrue2011-08-25NUCYNTA ER

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6071970 (view patent)2017-06-06NDA200533, NDA022304, NDA203794tapentadol Oral Tablet
tapentadol Oral Solution
2p7994364 (view patent)2025-06-27NDA200533, NDA022304, NDA203794tapentadol Oral Tablet
tapentadol Oral Solution
3p8075872 (view patent)2023-11-20NDA200533, NDA201655Oxymorphone Extended Release Oral Tablet
4p8114383 (view patent)2024-10-10NDA200533, NDA022272, NDA201655Oxymorphone Extended Release Oral Tablet
Oxycodone Extended Release Oral Tablet
5p8309060 (view patent)2023-11-20NDA200533, NDA022272, NDA201655, NDA206627Oxymorphone Extended Release Oral Tablet
Oxycodone Extended Release Oral Tablet
Hydrocodone Extended Release Oral Tablet
6p8420056 (view patent)2023-11-20NDA200533
7p8536130 (view patent)2028-09-22NDA200533
8pRE39593 (view patent)2022-08-05NDA200533, NDA022304, NDA203794tapentadol Oral Tablet
tapentadol Oral Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18aac7e48-f10c-4623-8fb5-1d74d5e22520 (view SPL)These highlights do not include all the information needed to use NUCYNTA ER safely and effectively. See full prescribing information for NUCYNTA ER.NUCYNTA ER (tapentadol) extended-release oral tablets C-IIInitial U.S. Approval: 2008prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-10-041353560770
2a9a13367-b5f0-4255-ae6a-8f558d90cd07 (view SPL)These highlights do not include all the information needed to use NUCYNTA ER safely and effectively. See full prescribing information for NUCYNTA ER.NUCYNTA ER (tapentadol) extended-release oral tablets C-IIInitial U.S. Approval: 2008prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2013-02-121353560810
3f4c911f3-484b-44fa-833e-2d970d39be8f (view SPL)These highlights do not include all the information needed to use NUCYNTA ER safely and effectively. See full prescribing information for NUCYNTA ER. NUCYNTA ER (tapentadol) extended-release oral tablets C-IIInitial U.S. Approval: 2008prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-04-256504580860, 504580861, 504580862, 504580863, 504580864

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII