Comtan

Product NDC
0078-0327
11-digit product format
000780327
Labeler code
0078
Product ID
0078-0327_82fdf87b-0cad-4f0b-900e-500e481a2d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020796
Marketing category
NDA
Marketing start
1999-10-19
Marketing end
2022-04-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0327-05EA - Each0078-0327e1593f63-0a3d-4e17-a1ee-39708686683012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0327-0500078032705100 TABLET, FILM COATED in 1 BOTTLE (0078-0327-05) 1999-10-192022-04-30NoNoCurrent