NDC 61919-515

VALACYCLOVIR

Valacyclovir

VALACYCLOVIR is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Valacyclovir Hydrochloride.

Product ID61919-515_874aa629-1333-0c30-e053-2a95a90ac888
NDC61919-515
Product TypeHuman Prescription Drug
Proprietary NameVALACYCLOVIR
Generic NameValacyclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA077135
Labeler NameDirectRX
Substance NameVALACYCLOVIR HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesDNA 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-515-20

20 TABLET in 1 BOTTLE (61919-515-20)
Marketing Start Date2019-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-515-20 [61919051520]

VALACYCLOVIR TABLET
Marketing CategoryANDA
Application NumberANDA077135
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-24

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:874aa629-1332-0c30-e053-2a95a90ac888
Manufacturer
UNII

Pharmacological Class

  • 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]
  • 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 Crossover Matching brand name "VALACYCLOVIR" or generic name "Valacyclovir"

NDCBrand NameGeneric Name
0093-7258ValacyclovirValacyclovir
0093-7259ValacyclovirValacyclovir
31722-704ValacyclovirValacyclovir
31722-705ValacyclovirValacyclovir
43063-771ValacyclovirValacyclovir
43353-883ValacyclovirValacyclovir Hydrochloride
50090-2510ValacyclovirValacyclovir
50090-2575ValacyclovirValacyclovir
50436-0704ValacyclovirValacyclovir
50436-7050ValacyclovirValacyclovir
51407-107ValacyclovirValacyclovir
51407-108ValacyclovirValacyclovir
51660-904VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
51660-905VALACYCLOVIRVALACYCLOVIR HYDROCHLORIDE
52343-051Valacyclovirvalacyclovir hydrochloride
52343-052Valacyclovirvalacyclovir hydrochloride
55700-913ValacyclovirValacyclovir
60760-469ValacyclovirValacyclovir
61919-066ValacyclovirValacyclovir
61919-515VALACYCLOVIRVALACYCLOVIR
61919-919ValacyclovirValacyclovir
68071-3135ValacyclovirValacyclovir
68071-3276ValacyclovirValacyclovir
68071-3372ValacyclovirValacyclovir
68071-4805ValacyclovirValacyclovir
68382-226ValacyclovirValacyclovir
68382-225ValacyclovirValacyclovir
70518-0323ValacyclovirValacyclovir
70934-106ValacyclovirValacyclovir
71335-0630ValacyclovirValacyclovir
63187-950ValacyclovirValacyclovir
63304-904ValacyclovirValacyclovir
63304-905ValacyclovirValacyclovir
65841-630ValacyclovirValacyclovir
65841-629ValacyclovirValacyclovir
63629-7958ValacyclovirValacyclovir
70518-2402ValacyclovirValacyclovir
68071-3332ValacyclovirValacyclovir
0378-4275Valacyclovir Hydrochloridevalacyclovir
0378-4276Valacyclovir Hydrochloridevalacyclovir

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