NDC 50771-013

ENTECAVIR

Entecavir

ENTECAVIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Yaopharma Co., Ltd.. The primary component is Entecavir.

Product ID50771-013_9695198d-5de1-0cb7-e053-2a95a90a0885
NDC50771-013
Product TypeHuman Prescription Drug
Proprietary NameENTECAVIR
Generic NameEntecavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA212201
Labeler NameYaopharma Co., Ltd.
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 Through2020-12-31

Packaging

NDC 50771-013-01

30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01)
Marketing Start Date2020-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50771-013-02 [50771001302]

ENTECAVIR TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212201
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

NDC 50771-013-01 [50771001301]

ENTECAVIR TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212201
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
ENTECAVIR.5 mg/1

Pharmacological Class

  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleoside Analog [EXT]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]

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.