Home NDC 68382-225 Valacyclovir
Product NDC 68382-225
11-digit product format 683820225
Labeler code 68382
Product ID 68382-225_3e77dc44-b8f3-41aa-a857-300bf4fcd8ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA079137
Marketing category ANDA
Marketing start 2018-04-05
Marketing end 0000-00-00
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
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 Units Marketing start Marketing end Sample Exclude flag Status 68382-225-01 68382022501 100 TABLET, FILM COATED in 1 BOTTLE (68382-225-01) 2018-04-05 0000-00-00 No No Current 68382-225-06 68382022506 30 TABLET, FILM COATED in 1 BOTTLE (68382-225-06) 2018-04-05 0000-00-00 No No Current 68382-225-10 68382022510 1000 TABLET, FILM COATED in 1 BOTTLE (68382-225-10) 2018-04-05 0000-00-00 No No Current 68382-225-77 68382022577 10 BLISTER PACK in 1 CARTON (68382-225-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2018-04-05 0000-00-00 No No Current