Entecavir

Product NDC
62227-102
11-digit product format
622270102
Labeler code
62227
Product ID
62227-102_9f4c7e78-9c8c-5330-e053-2a95a90aa6af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entecavir
Dosage form
TABLET
Route
ORAL
Labeler
BrightGene Bio-Medical Technology Co., Ltd.
Application
ANDA212126
Marketing category
ANDA
Marketing start
2019-03-08
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62227-102-016222701020130 TABLET in 1 BOTTLE, PLASTIC (62227-102-01) 30 tablet2019-03-080000-00-00NoNoCurrent
62227-102-02622270102021500 TABLET in 1 BOTTLE, PLASTIC (62227-102-02) 1500 tablet2019-03-080000-00-00NoNoCurrent