FDA.reportPublic FDA data

NUCYNTA

Product NDC
50458-830
11-digit product format
504580830
Labeler code
50458
Product ID
50458-830_926544cc-122c-4f9f-9434-a886827b0871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA022304
Marketing category
NDA
Marketing start
2009-06-01
Marketing end
2020-03-31
Substance
TAPENTADOL HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-830-02EA - Each50458-8307dfc1698-3dac-48bb-9b9d-fb9cee94b77b12012-07-24
50458-830-04EA - Each50458-830e92b5905-e0d0-4bb6-8fb8-4824982775bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAPENTADOL HYDROCHLORIDEACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TAPENTADOLACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TAPENTADOL HYDROCHLORIDEACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
TAPENTADOLACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854140NUCYNTA 100 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142NUCYNTA 50 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144NUCYNTA 75 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140tapentadol 100 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142tapentadol 50 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144tapentadol 75 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140Nucynta 100 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142Nucynta 50 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144Nucynta 75 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144NUCYNTA 75 MG Oral TabletPSNba3db17e-5697-46f0-8fb3-dd19e93e1a081
825413tapentadol 75 MG Oral TabletPSNba3db17e-5697-46f0-8fb3-dd19e93e1a081
854144tapentadol 75 MG Oral Tablet [Nucynta]SBDba3db17e-5697-46f0-8fb3-dd19e93e1a081
825413tapentadol 75 MG Oral TabletSCDba3db17e-5697-46f0-8fb3-dd19e93e1a081
854144Nucynta 75 MG Oral TabletSYba3db17e-5697-46f0-8fb3-dd19e93e1a081
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSYba3db17e-5697-46f0-8fb3-dd19e93e1a081