NDC 35573-403

Acyclovir

Acyclovir

Acyclovir is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Llc. The primary component is Acyclovir.

Product ID35573-403_1d2f958a-a6ef-4867-99b2-e76adac462cc
NDC35573-403
Product TypeHuman Prescription Drug
Proprietary NameAcyclovir
Generic NameAcyclovir
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2019-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA205591
Labeler NameBurel Pharmaceuticals, LLC
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 35573-403-15

1 TUBE in 1 CARTON (35573-403-15) > 15 g in 1 TUBE
Marketing Start Date2019-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-403-31 [35573040331]

Acyclovir OINTMENT
Marketing CategoryANDA
Application NumberANDA205591
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-09

NDC 35573-403-15 [35573040315]

Acyclovir OINTMENT
Marketing CategoryANDA
Application NumberANDA205591
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-09

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR50 mg/g

OpenFDA Data

SPL SET ID:3b5db3a5-a875-466a-a156-b05377404e83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197312
  • UPC Code
  • 0335573403317
  • 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]
    • 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.