Entacapone

Product NDC
43353-996
11-digit product format
433530996
Labeler code
43353
Product ID
43353-996_7c029405-5ed3-4194-9dc9-a295dc779170
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
Marketing start
2012-09-30
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-996-05Entacapone4200 in 1 BOTTLETABLET, FILM COATED42003
43353-996-83Entacapone3600 in 1 BOTTLETABLET, FILM COATED36003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-996-05EA - Each43353-996ce108635-5574-42f4-a631-6dc1cdfddcaa12016-07-19
43353-996-83EA - Each43353-996539d50c8-417d-4684-b660-9d5b335ed9f512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-996ENTACAPONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 2 package rows20191231_78278e3a-cc95-49ac-89ea-b49f0d63fc46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317094entacapone 200 MG Oral TabletPSN78278e3a-cc95-49ac-89ea-b49f0d63fc463
317094entacapone 200 MG Oral TabletSCD78278e3a-cc95-49ac-89ea-b49f0d63fc463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-996-05433530996054200 TABLET, FILM COATED in 1 BOTTLE (43353-996-05) 2015-02-140000-00-00NoNoCurrent
43353-996-83433530996833600 TABLET, FILM COATED in 1 BOTTLE (43353-996-83) 2017-09-080000-00-00NoNoCurrent