NDC 71921-195

Entecavir

Entecavir

Entecavir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Florida Pharmaceutical Products, Llc. The primary component is Entecavir.

Product ID71921-195_b94f9be0-8dc2-0340-e053-2995a90adfc2
NDC71921-195
Product TypeHuman Prescription Drug
Proprietary NameEntecavir
Generic NameEntecavir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-02-26
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA212106
Labeler NameFlorida Pharmaceutical Products, LLC
Substance NameENTECAVIR
Active Ingredient Strength1 mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71921-195-33

30 TABLET in 1 BOTTLE (71921-195-33)
Marketing Start Date2021-02-26
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Entecavir" or generic name "Entecavir"

NDCBrand NameGeneric Name
0093-5786EntecavirEntecavir
0093-5787EntecavirEntecavir
10135-615EntecavirEntecavir
10135-616EntecavirEntecavir
16714-717ENTECAVIRENTECAVIR
16714-718ENTECAVIRENTECAVIR
16729-388EntecavirEntecavir
16729-389EntecavirEntecavir
31722-833EntecavirEntecavir
31722-834EntecavirEntecavir
42291-261EntecavirEntecavir
42291-262EntecavirEntecavir
68382-920EntecavirEntecavir
68382-921EntecavirEntecavir
69097-425ENTECAVIRENTECAVIR
69097-426ENTECAVIRENTECAVIR
70771-1019EntecavirEntecavir
70771-1020EntecavirEntecavir
43547-437ENTECAVIRENTECAVIR
43547-436ENTECAVIRENTECAVIR
49884-547EntecavirEntecavir
49884-548EntecavirEntecavir
51407-065EntecavirEntecavir
51407-064EntecavirEntecavir
52343-147ENTECAVIRENTECAVIR
51991-896EntecavirEntecavir
51991-895EntecavirEntecavir
52343-148ENTECAVIRENTECAVIR
60687-216EntecavirEntecavir
65162-446EntecavirEntecavir
65862-842EntecavirEntecavir
65162-449EntecavirEntecavir
65862-841EntecavirEntecavir
62227-102EntecavirEntecavir
62227-101EntecavirEntecavir
0003-1611BARACLUDEentecavir
0003-1612BARACLUDEentecavir
0003-1614BARACLUDEentecavir

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.