NDC 0168-0825

acyclovir

Acyclovir

acyclovir is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Acyclovir.

Product ID0168-0825_8e837af0-1db2-496d-bf80-939c6dd0d371
NDC0168-0825
Product TypeHuman Prescription Drug
Proprietary Nameacyclovir
Generic NameAcyclovir
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2016-05-11
Marketing CategoryANDA / ANDA
Application NumberANDA206633
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameACYCLOVIR
Active Ingredient Strength50 mg/g
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 0168-0825-15

1 TUBE in 1 CARTON (0168-0825-15) > 15 g in 1 TUBE
Marketing Start Date2016-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0825-30 [00168082530]

acyclovir OINTMENT
Marketing CategoryANDA
Application NumberANDA206633
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-05-11

NDC 0168-0825-15 [00168082515]

acyclovir OINTMENT
Marketing CategoryANDA
Application NumberANDA206633
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-11-01

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR50 mg/g

OpenFDA Data

SPL SET ID:d2d4fb8b-cd9d-45a3-90cd-3805a9441240
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197312
  • 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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