NDC 43353-933

Acyclovir

Acyclovir

Acyclovir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Acyclovir.

Product ID43353-933_32129338-bb18-4c4b-80a2-57ee2631feeb
NDC43353-933
Product TypeHuman Prescription Drug
Proprietary NameAcyclovir
Generic NameAcyclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA077309
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameACYCLOVIR
Active Ingredient Strength800 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 Through2019-12-31

Packaging

NDC 43353-933-18

3000 TABLET in 1 BOTTLE, PLASTIC (43353-933-18)
Marketing Start Date2012-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-933-18 [43353093318]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR800 mg/1

OpenFDA Data

SPL SET ID:eb863c4f-4e39-4d97-8b7e-30a76fe2119d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197313
  • 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 "Acyclovir" or generic name "Acyclovir"

    NDCBrand NameGeneric Name
    0093-3630Acycloviracyclovir
    0093-8940AcyclovirAcyclovir
    0093-8943AcyclovirAcyclovir
    0093-8947AcyclovirAcyclovir
    0143-9657AcyclovirAcyclovir
    0143-9658AcyclovirAcyclovir
    0168-0825acycloviracyclovir
    0378-8700Acycloviracyclovir
    0378-8712AcyclovirAcyclovir
    0440-6030AcyclovirAcyclovir
    0440-7033acycloviracyclovir
    0472-0082AcyclovirAcyclovir
    0591-1159Acycloviracyclovir
    0713-0630AcyclovirAcyclovir
    0904-5789ACYCLOVIRACYCLOVIR
    0904-5790acycloviracyclovir
    10544-039Acycloviracyclovir
    10544-089Acycloviracyclovir
    10544-101AcyclovirAcyclovir
    68071-1841AcyclovirAcyclovir
    68071-3155AcyclovirAcyclovir
    68071-3222AcyclovirAcyclovir
    68071-4528AcyclovirAcyclovir
    68071-4559acycloviracyclovir
    68071-4345AcyclovirAcyclovir
    68084-109AcyclovirAcyclovir
    68084-108AcyclovirAcyclovir
    68071-4790AcyclovirAcyclovir
    68071-4799AcyclovirAcyclovir
    68084-107ACYCLOVIRACYCLOVIR
    68382-125acycloviracyclovir
    68382-049acycloviracyclovir
    68382-048acycloviracyclovir
    68382-668acycloviracyclovir
    68382-126acycloviracyclovir
    68382-792acycloviracyclovir
    68382-791acycloviracyclovir
    68382-992acycloviracyclovir
    68462-746acycloviracyclovir
    68788-6360acycloviracyclovir
    68788-0505AcyclovirAcyclovir
    68788-0504AcyclovirAcyclovir
    68788-0715AcyclovirAcyclovir
    68788-8989acycloviracyclovir
    68788-6827ACYCLOVIRACYCLOVIR
    68788-7382acycloviracyclovir
    68788-7378acycloviracyclovir
    68788-9783AcyclovirAcyclovir
    68788-7342AcyclovirAcyclovir
    68788-9690AcyclovirAcyclovir

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.