FDA.reportPublic FDA data

Nucynta

Product NDC
69865-240
11-digit product format
698650240
Labeler code
69865
Product ID
69865-240_48a5c0ae-e4e1-47ad-bfc5-3d56558e0cba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Depo NF Sub, LLC
Application
NDA200533
Marketing category
NDA
Marketing start
2017-06-16
Marketing end
0000-00-00
Substance
TAPENTADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
279f6ab2-ad0d-a4be-abc3-377fa3441fa2Product name120140508
41331914-7851-9471-14c3-fea0cf65689eProduct name120140508
7142c439-ef45-40fb-d30b-dd20e4faf1c1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69865-240-012021-01-29C16284748780-1ba0f9c33-4df9-a910-e053-dadaa90a0b85These 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 tablets for oral use C-II Initial U.S. Approval: 2008
69865-240-022021-01-29C16284748780-1ba0f9c33-4df9-a910-e053-dadaa90a0b85These 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 tablets for oral use C-II Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69865-240-01NucyntaER10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE105
69865-240-01NucyntaER10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE105
69865-240-02NucyntaER60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69865-240-02EA - Each69865-2409577472f-aec3-4d58-bf54-4e5d99b067ca12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69865-240NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPO NF SUB, LLC]5Legacy NDC, 3 package rows20190223_40671852-846e-4bc1-8e15-1f71add24414.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1149367Nucynta ER 100 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1149370Nucynta ER 150 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1149373Nucynta ER 200 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1149376Nucynta ER 250 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1149378Nucynta ER 50 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1148797tapentadol 100 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1148800tapentadol 150 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1148803tapentadol 200 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1148807tapentadol 250 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
1148809tapentadol 50 MG 12HR Extended Release Oral TabletPSN40671852-846e-4bc1-8e15-1f71add244145
114936712 HR tapentadol 100 MG Extended Release Oral Tablet [Nucynta]SBD40671852-846e-4bc1-8e15-1f71add244145
114937012 HR tapentadol 150 MG Extended Release Oral Tablet [Nucynta]SBD40671852-846e-4bc1-8e15-1f71add244145
114937312 HR tapentadol 200 MG Extended Release Oral Tablet [Nucynta]SBD40671852-846e-4bc1-8e15-1f71add244145
114937612 HR tapentadol 250 MG Extended Release Oral Tablet [Nucynta]SBD40671852-846e-4bc1-8e15-1f71add244145
114937812 HR tapentadol 50 MG Extended Release Oral Tablet [Nucynta]SBD40671852-846e-4bc1-8e15-1f71add244145
114879712 HR tapentadol 100 MG Extended Release Oral TabletSCD40671852-846e-4bc1-8e15-1f71add244145
114880012 HR tapentadol 150 MG Extended Release Oral TabletSCD40671852-846e-4bc1-8e15-1f71add244145
114880312 HR tapentadol 200 MG Extended Release Oral TabletSCD40671852-846e-4bc1-8e15-1f71add244145
114880712 HR tapentadol 250 MG Extended Release Oral TabletSCD40671852-846e-4bc1-8e15-1f71add244145
114880912 HR tapentadol 50 MG Extended Release Oral TabletSCD40671852-846e-4bc1-8e15-1f71add244145
114936712 HR Nucynta 100 MG Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
114937012 HR Nucynta 150 MG Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
114937312 HR Nucynta 200 MG Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
114937612 HR Nucynta 250 MG Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
114937812 HR Nucynta 50 MG Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
1149367Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
1149370Nucynta 150 MG (tapentadol hydrochloride 174.72 MG) 12 HR Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
1149373Nucynta 200 MG (tapentadol hydrochloride 232.96 MG) 12 HR Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
1149376Nucynta 250 MG (tapentadol hydrochloride 291.20 MG) 12 HR Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145
1149378Nucynta 50 MG (tapentadol hydrochloride 58.24 MG) 12 HR Extended Release Oral TabletSY40671852-846e-4bc1-8e15-1f71add244145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69865-240-016986502400110 in 1 BLISTER PACKHistorical
69865-240-026986502400260 in 1 BOTTLEHistorical