FDA.reportPublic FDA data

NUCYNTA

Product NDC
50458-820
11-digit product format
504580820
Labeler code
50458
Product ID
50458-820_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
50 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
50458-820-02EA - Each50458-820d5cd964f-05a6-461d-bebf-2c186b99599312012-07-24
50458-820-04EA - Each50458-82001477a39-a71f-46cd-bb55-3abeb078a9b712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAPENTADOL HYDROCHLORIDEACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
tapentadol hydrochlorideACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
tapentadolACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]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
aluminum oxideINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]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
magnesium stearateINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]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
talcINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
tapentadol hydrochlorideACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
tapentadolACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854140NUCYNTA 100 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
854140NUCYNTA 100 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142NUCYNTA 50 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
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
825409tapentadol 100 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
825411tapentadol 50 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
825413tapentadol 75 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140tapentadol 100 MG Oral Tablet [Nucynta]SBDe35e8385-db1f-41a8-8307-20979569ac722
854140tapentadol 100 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142tapentadol 50 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142tapentadol 50 MG Oral Tablet [Nucynta]SBDe35e8385-db1f-41a8-8307-20979569ac722
854144tapentadol 75 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG Oral TabletSCDe35e8385-db1f-41a8-8307-20979569ac722
825409tapentadol 100 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletSCDe35e8385-db1f-41a8-8307-20979569ac722
825413tapentadol 75 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140Nucynta 100 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140Nucynta 100 MG Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
854142Nucynta 50 MG Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
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
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142NUCYNTA 50 MG Oral TabletPSN7997e6da-7e98-4520-9d1b-0b8341bac64a1
825411tapentadol 50 MG Oral TabletPSN7997e6da-7e98-4520-9d1b-0b8341bac64a1
854142tapentadol 50 MG Oral Tablet [Nucynta]SBD7997e6da-7e98-4520-9d1b-0b8341bac64a1
825411tapentadol 50 MG Oral TabletSCD7997e6da-7e98-4520-9d1b-0b8341bac64a1
854142Nucynta 50 MG Oral TabletSY7997e6da-7e98-4520-9d1b-0b8341bac64a1
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSY7997e6da-7e98-4520-9d1b-0b8341bac64a1