Valacyclovir

Product NDC
68382-226
11-digit product format
683820226
Labeler code
68382
Product ID
68382-226_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
1000 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 NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-226-066838202260630 TABLET, FILM COATED in 1 BOTTLE (68382-226-06) 2018-04-050000-00-00NoNoCurrent
68382-226-10683820226101000 TABLET, FILM COATED in 1 BOTTLE (68382-226-10) 2018-04-050000-00-00NoNoCurrent
68382-226-346838202263421 TABLET, FILM COATED in 1 BOTTLE (68382-226-34) 2018-04-050000-00-00NoNoCurrent