Home NDC 53104-0101 Zidovudine
Product NDC 53104-0101
11-digit product format 531040101
Labeler code 53104
Product ID 53104-0101_ff6fca1f-8ccf-493d-a0a4-ca906e5ad7d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla Ltd.
Application ANDA090561
Marketing category ANDA
Marketing start 2010-10-27
Marketing end 0000-00-00
Substance ZIDOVUDINE
Active strength 300 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53104-0101-2 53104010102 60 TABLET, FILM COATED in 1 BOTTLE (53104-0101-2) 2010-10-27 0000-00-00 No No Current 53104-0101-6 53104010106 1000 TABLET, FILM COATED in 1 BOTTLE (53104-0101-6) 2010-10-27 0000-00-00 No No Current 53104-0101-9 53104010109 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (53104-0101-9) 2010-10-27 0000-00-00 No No Current