FDA.reportPublic FDA data

Nucynta

Product NDC
24510-116
11-digit product format
245100116
Labeler code
24510
Product ID
24510-116_2d370c0d-8d66-446f-be46-ed92e0f1cf6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Collegium Pharmaceutical, Inc.
Application
NDA200533
Marketing category
NDA
Marketing start
2019-04-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nucynta
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAPENTADOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71204KII53
Rxcui1148797, 1148800, 1148803, 1148807, 1148809, 1149367, 1149370, 1149373, 1149376, 1149378

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24510-116-01NucyntaER10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE108
24510-116-01NucyntaER10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE108
24510-116-60NucyntaER60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24510-116-60EA - Each24510-1166005b656-8842-4b6e-82ee-6baade1e1a0712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24510-116NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [COLLEGIUM PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 3 package rows20231223_c3d04d70-0155-4147-9ce4-a3b1fad4b373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1149367Nucynta ER 100 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149370Nucynta ER 150 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149373Nucynta ER 200 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149376Nucynta ER 250 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149378Nucynta ER 50 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1148797tapentadol 100 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1148800tapentadol 150 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1148803tapentadol 200 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1148807tapentadol 250 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1148809tapentadol 50 MG 12HR Extended Release Oral TabletPSNc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114936712 HR tapentadol 100 MG Extended Release Oral Tablet [Nucynta]SBDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937012 HR tapentadol 150 MG Extended Release Oral Tablet [Nucynta]SBDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937312 HR tapentadol 200 MG Extended Release Oral Tablet [Nucynta]SBDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937612 HR tapentadol 250 MG Extended Release Oral Tablet [Nucynta]SBDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937812 HR tapentadol 50 MG Extended Release Oral Tablet [Nucynta]SBDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114879712 HR tapentadol 100 MG Extended Release Oral TabletSCDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114880012 HR tapentadol 150 MG Extended Release Oral TabletSCDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114880312 HR tapentadol 200 MG Extended Release Oral TabletSCDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114880712 HR tapentadol 250 MG Extended Release Oral TabletSCDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114880912 HR tapentadol 50 MG Extended Release Oral TabletSCDc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114936712 HR Nucynta 100 MG Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937012 HR Nucynta 150 MG Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937312 HR Nucynta 200 MG Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937612 HR Nucynta 250 MG Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
114937812 HR Nucynta 50 MG Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149367Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149370Nucynta 150 MG (tapentadol hydrochloride 174.72 MG) 12 HR Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149373Nucynta 200 MG (tapentadol hydrochloride 232.96 MG) 12 HR Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149376Nucynta 250 MG (tapentadol hydrochloride 291.20 MG) 12 HR Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738
1149378Nucynta 50 MG (tapentadol hydrochloride 58.24 MG) 12 HR Extended Release Oral TabletSYc3d04d70-0155-4147-9ce4-a3b1fad4b3738

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24510-116-012451001160110 BLISTER PACK in 1 CARTON (24510-116-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-04-190000-00-00NoNoCurrent
24510-116-602451001166060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-116-60) 2019-04-190000-00-00NoNoCurrent