ENTECAVIR

Product NDC
48792-7891
11-digit product format
487927891
Labeler code
48792
Product ID
48792-7891_a6b0bc76-b6a9-601c-e053-2a95a90aade3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENTECAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA211978
Marketing category
ANDA
Marketing start
2020-05-20
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7891-14879278910130 TABLET, FILM COATED in 1 BOTTLE (48792-7891-1) 2020-05-200000-00-00NoNoCurrent
48792-7891-24879278910290 TABLET, FILM COATED in 1 BOTTLE (48792-7891-2) 2020-05-200000-00-00NoNoCurrent