NDC 55289-462

Acyclovir

Acyclovir

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

Product ID55289-462_7bc02915-7881-c23b-e053-2a91aa0ac766
NDC55289-462
Product TypeHuman Prescription Drug
Proprietary NameAcyclovir
Generic NameAcyclovir
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1997-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA074556
Labeler NamePD-Rx 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 Through2019-12-31

Packaging

NDC 55289-462-05

5 TABLET in 1 BOTTLE, PLASTIC (55289-462-05)
Marketing Start Date2004-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-462-60 [55289046260]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-04-07
Marketing End Date2019-09-12

NDC 55289-462-40 [55289046240]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-15
Marketing End Date2019-09-12

NDC 55289-462-35 [55289046235]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-22
Marketing End Date2019-09-12

NDC 55289-462-15 [55289046215]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-04-02
Marketing End Date2019-09-12

NDC 55289-462-30 [55289046230]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-04-02
Marketing End Date2019-09-12

NDC 55289-462-12 [55289046212]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-04-02
Marketing End Date2019-09-12

NDC 55289-462-05 [55289046205]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-01-05
Marketing End Date2019-09-12

NDC 55289-462-21 [55289046221]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-08-29
Marketing End Date2019-09-12

NDC 55289-462-04 [55289046204]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-03
Marketing End Date2019-09-12

NDC 55289-462-25 [55289046225]

Acyclovir TABLET
Marketing CategoryANDA
Application NumberANDA074556
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-04-02
Marketing End Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR400 mg/1

OpenFDA Data

SPL SET ID:e947e72f-b5e1-4a5a-a7f6-58c2c8a387cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197311
  • UPC Code
  • 0355289462057
  • 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.