Entacapone

Product NDC
48792-7830
11-digit product format
487927830
Labeler code
48792
Product ID
48792-7830_77c463d8-84d8-231c-e053-2a91aa0a9fe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA206669
Marketing category
ANDA
Marketing start
2018-10-10
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7830-14879278300160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7830-1) 2018-10-100000-00-00NoNoCurrent
48792-7830-248792783002100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7830-2) 2018-10-100000-00-00NoNoCurrent