ENTECAVIR

Product NDC
50268-289
11-digit product format
502680289
Labeler code
50268
Product ID
50268-289_d5cef9cd-9b5f-8bbc-e053-2995a90a2c7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENTECAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA208782
Marketing category
ANDA
Marketing start
2020-10-06
Marketing end
0000-00-00
Substance
ENTECAVIR ANHYDROUS
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-289-125026802891220 BLISTER PACK in 1 BOX (50268-289-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-289-11) 20 blister pack2020-10-060000-00-00NoNoCurrent