Acyclovir 400 mg/1
Acyclovir · TABLET · NuCare Pharmaceuticals,Inc.
Acyclovir is an oral antiviral medication used to treat infections caused by herpes simplex virus, including cold sores and genital herpes. It works by inhibiting the virus's ability to replicate and spread in the body.
Key Facts
- Brand Name
- Acyclovir
- Generic Name
- Acyclovir
- NDC Code (Product)
68071-3573- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 400 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209366
- Drug Class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Marketing Start
- 08/15/2020
Recall History
Walgreens Infusion Services
Lack of sterility assurance.
Aidapak Services, LLC
Labeling: Label Mixup: ACYCLOVIR, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD60240_51, EXP: 5/22/2014; METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W002841, EXP: 6/7/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003900, EXP: 6/27/2014; acetaZOLAMIDE
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Aidapak Services, LLC
Labeling: Label Mixup: ACYCLOVIR, Tablet, 800 mg may have potentially been mislabeled as the following drug: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 64679043304, Pedigree: AD70690_4, EXP: 5/29/2014.
Zydus Pharmaceuticals USA Inc
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Heritage Pharmaceuticals Inc
Labeling: Incorrect or Missing Lot and/or Exp Date
Hi-Tech Pharmacal Co., Inc.
Failed Stability Specification; product viscosity and or pH are below specification.
Zydus Pharmaceuticals (USA) Inc
Crystallization: customer complaints for crystallization in finished product.
Eugia US LLC
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Apace KY LLC
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Herpes Zoster Infections : Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes : Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox : Acyclovir is indicated for the treatment of chickenpox (varicella).
Dosage & Administration
DOSAGE AND ADMINISTRATION Acute Treatment of Herpes Zoster : 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes : Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days. Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient's genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir. Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence. Treatment of Chickenpox : Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zost…
Warnings
WARNINGS Acyclovir capsules are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
Contraindications
CONTRAINDICATIONS Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Drug Interactions
Drug Interactions: See CLINICAL PHARMACOLOGY: Pharmacokinetics .
Adverse Reactions
ADVERSE REACTIONS Herpes Simplex: Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo. Long-Term Administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). Herpes Zoster : The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%). Chickenpox : The most frequent adverse event reported during 3 clinical trials of treatm…
Frequently Asked Questions
What is Acyclovir used for?
Acyclovir is an oral antiviral medication used to treat infections caused by herpes simplex virus, including cold sores and genital herpes. It works by inhibiting the virus's ability to replicate and spread in the body.
Is Acyclovir a controlled substance?
Acyclovir is not classified as a controlled substance by the DEA.
What is the generic name for Acyclovir?
The generic name for Acyclovir is Acyclovir. There are 2 other brand versions of Acyclovir.
What is the NDC code for Acyclovir 400 mg/1?
The NDC (National Drug Code) for Acyclovir 400 mg/1 is 68071-3573, listed by NuCare Pharmaceuticals,Inc..