NDC 61919-919

Valacyclovir

Valacyclovir

Valacyclovir is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Valacyclovir Hydrochloride.

Product ID61919-919_35e38d4b-d11f-43f9-e054-00144ff8d46c
NDC61919-919
Product TypeHuman Prescription Drug
Proprietary NameValacyclovir
Generic NameValacyclovir
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077478
Labeler NameDirect Rx
Substance NameVALACYCLOVIR HYDROCHLORIDE
Active Ingredient Strength1 g/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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-919-04

4 CAPSULE in 1 BOTTLE (61919-919-04)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-919-04 [61919091904]

Valacyclovir CAPSULE
Marketing CategoryANDA
Application NumberANDA077478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

NDC 61919-919-71 [61919091971]

Valacyclovir CAPSULE
Marketing CategoryANDA
Application NumberANDA077478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01

NDC 61919-919-21 [61919091921]

Valacyclovir CAPSULE
Marketing CategoryANDA
Application NumberANDA077478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:536aaf2c-9ce6-4eb9-973d-343d01a262fc
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]

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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