Entecavir

Product NDC
63126-102
11-digit product format
631260102
Labeler code
63126
Product ID
63126-102_296df15a-92f7-4bec-916b-441fc1c71b3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
YUNG SHIN PHARM. IND. CO., LTD.
Application
ANDA208195
Marketing category
ANDA
Marketing start
2022-04-30
Marketing end
0000-00-00
Substance
ENTECAVIR
Active strength
1 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63126-102-306312601023030 TABLET, FILM COATED in 1 BOTTLE (63126-102-30) 2022-04-300000-00-00NoNoCurrent