Nucynta

Product NDC
69865-230
11-digit product format
698650230
Labeler code
69865
Product ID
69865-230_7134a790-af25-4843-bf3f-c768fac42fcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Depo NF Sub, LLC
Application
NDA022304
Marketing category
NDA
Marketing start
2017-06-16
Marketing end
0000-00-00
Substance
TAPENTADOL HYDROCHLORIDE
Active strength
100 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69865-230-01Nucynta10 in 1 BLISTER PACKTABLET, FILM COATED105
69865-230-01Nucynta10 in 1 CARTONTABLET, FILM COATED105
69865-230-02Nucynta100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69865-230-02EA - Each69865-230a786914e-9af4-4b1d-88a2-22a0488b57d612017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69865-230NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [DEPO NF SUB, LLC]5Legacy NDC, 3 package rows20190223_ad05d6a0-addc-46e9-a5bd-7892b262b090.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854140NUCYNTA 100 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
854142NUCYNTA 50 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
854144NUCYNTA 75 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
825409tapentadol 100 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
825411tapentadol 50 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
825413tapentadol 75 MG Oral TabletPSNad05d6a0-addc-46e9-a5bd-7892b262b0905
854140tapentadol 100 MG Oral Tablet [Nucynta]SBDad05d6a0-addc-46e9-a5bd-7892b262b0905
854142tapentadol 50 MG Oral Tablet [Nucynta]SBDad05d6a0-addc-46e9-a5bd-7892b262b0905
854144tapentadol 75 MG Oral Tablet [Nucynta]SBDad05d6a0-addc-46e9-a5bd-7892b262b0905
825409tapentadol 100 MG Oral TabletSCDad05d6a0-addc-46e9-a5bd-7892b262b0905
825411tapentadol 50 MG Oral TabletSCDad05d6a0-addc-46e9-a5bd-7892b262b0905
825413tapentadol 75 MG Oral TabletSCDad05d6a0-addc-46e9-a5bd-7892b262b0905
854140Nucynta 100 MG Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905
854142Nucynta 50 MG Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905
854144Nucynta 75 MG Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSYad05d6a0-addc-46e9-a5bd-7892b262b0905

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69865-230-016986502300110 in 1 BLISTER PACKHistorical
69865-230-0269865023002100 in 1 BOTTLEHistorical