NDC 35356-903

Acyclovir

Acyclovir

Acyclovir is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Acyclovir.

Product ID35356-903_29c8a6ff-f55c-497f-8421-43cb60d01e86
NDC35356-903
Product TypeHuman Prescription Drug
Proprietary NameAcyclovir
Generic NameAcyclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA077309
Labeler NameLake Erie Medical DBA Quality Care Products LLC
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 Through2023-12-31

Packaging

NDC 35356-903-40

40 TABLET in 1 BOTTLE (35356-903-40)
Marketing Start Date2013-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-903-40 [35356090340]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-21
Marketing End Date2019-06-30

NDC 35356-903-35 [35356090335]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-21
Marketing End Date2016-01-12

NDC 35356-903-25 [35356090325]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-21
Marketing End Date2019-06-30

NDC 35356-903-60 [35356090360]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-21
Marketing End Date2019-06-30

NDC 35356-903-15 [35356090315]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-21
Marketing End Date2019-06-30

NDC 35356-903-30 [35356090330]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-21
Marketing End Date2019-10-11

NDC 35356-903-90 [35356090390]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA077309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-21
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR400 mg/1

OpenFDA Data

SPL SET ID:ddb58351-ae60-4261-a932-aab0f6256ee5
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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