valacyclovir hydrochloride

Product NDC
55700-345
11-digit product format
557000345
Labeler code
55700
Product ID
55700-345_f1421eb4-94fb-4348-a877-874268c63407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA201506
Marketing category
ANDA
Marketing start
2012-04-05
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-345-21EA - Each55700-3451647d5f5-0ddc-45e6-b43f-2657d3ced27612016-05-16
55700-345-30EA - Each55700-3451414ca73-d249-4b55-b67b-8e4f72c96d0a12019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-345-215570003452121 TABLET, FILM COATED in 1 BOTTLE (55700-345-21) 2015-12-150000-00-00NoNoCurrent
55700-345-305570003453030 TABLET, FILM COATED in 1 BOTTLE (55700-345-30) 2015-12-150000-00-00NoNoCurrent