Entacapone

Product NDC
71610-247
11-digit product format
716100247
Labeler code
71610
Product ID
71610-247_a3c90a47-42cb-44b6-99e0-f027dc45ac2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020796
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-06-04
Substance
ENTACAPONE
Active strength
200 mg/1
Pharmacologic classes
Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Entacapone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENTACAPONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4975G9NM6T
Rxcui317094

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-247-83Entacapone3600 in 1 BOTTLETABLET, FILM COATED36001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-247-83EA - Each71610-247bb6bc8fc-9c63-41a5-b999-e75e1f6cb8a812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-247ENTACAPONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20190315_32d30f97-ae0f-4d02-bdd7-75e0783d66bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317094entacapone 200 MG Oral TabletPSN32d30f97-ae0f-4d02-bdd7-75e0783d66bc1
317094entacapone 200 MG Oral TabletSCD32d30f97-ae0f-4d02-bdd7-75e0783d66bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-247-83716100247833600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83) 2019-03-070000-00-00NoNoCurrent