NDC 53002-0081

Acyclovir

Acyclovir

Acyclovir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Acyclovir.

Product ID53002-0081_d8313650-50c3-4889-af0f-258cc032b028
NDC53002-0081
Product TypeHuman Prescription Drug
Proprietary NameAcyclovir
Generic NameAcyclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA202168
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameACYCLOVIR
Active Ingredient Strength400 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 Through2021-12-31

Packaging

NDC 53002-0081-1

15 TABLET in 1 BOTTLE (53002-0081-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-0081-9 [53002008109]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-4 [53002008104]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-2 [53002008102]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-1 [53002008101]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-6 [53002008106]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-5 [53002008105]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-0081-3 [53002008103]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA202168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR400 mg/1

OpenFDA Data

SPL SET ID:ea2a95c0-83ce-4f74-b1a5-64ba995253cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197311

    • 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
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