FDA.reportPublic FDA data

Entacapone

Product NDC
50268-295
11-digit product format
502680295
Labeler code
50268
Product ID
50268-295_47e3561c-c311-d3fd-e063-6394a90ae2cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA203437
Marketing category
ANDA
Marketing start
2016-12-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Entacapone
Listing expiration
2027-12-31

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
50268-295-11Entacapone1 in 1 BLISTER PACKTABLET, FILM COATED17
50268-295-15Entacapone50 in 1 BOX, UNIT-DOSETABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-295-11EA - Each50268-2958ca9bf70-9290-436b-a949-1d31ac012f4f12017-03-06
50268-295-15EA - Each50268-2952e20f940-66fc-4213-a60f-2221c0167d5312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-295ENTACAPONE TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20220517_1fab63f2-9257-6998-5658-7e98db51b184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317094entacapone 200 MG Oral TabletPSN1fab63f2-9257-6998-5658-7e98db51b1847
317094entacapone 200 MG Oral TabletSCD1fab63f2-9257-6998-5658-7e98db51b1847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-295-11502680295111 in 1 BLISTER PACKHistorical
50268-295-155026802951550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11) 50 blister pack2016-12-050000-00-00NoNoCurrent