Entecavir

Product NDC
0093-5786
11-digit product format
000935786
Labeler code
0093
Product ID
0093-5786_6b2d566d-fcd9-4913-a6ed-e7697e49101f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA202122
Marketing category
ANDA
Marketing start
2014-09-04
Marketing end
2021-04-30
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
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
0093-5786-56EA - Each0093-57860b0f7cd1-3561-4d83-ae05-2dfb3e84e83e12014-10-03
0093-5786-98EA - Each0093-578694684ac2-b138-40cd-8279-e9c55724d34712014-10-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5786-560009357865630 TABLET, FILM COATED in 1 BOTTLE (0093-5786-56) 2014-09-042021-04-30NoNoCurrent
0093-5786-980009357869890 TABLET, FILM COATED in 1 BOTTLE (0093-5786-98) 2014-09-042021-04-30NoNoCurrent