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Prescription medicine · generic available

Acyclovir

Brand names: Zovirax, Avaclyr

Also listed by the FDA as: acyclovir · acyclovir sodium

Drug class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
9Recalls (FDA reports)
66Companies
1982First FDA approval on file

Quick answers

What is Acyclovir used for?
The FDA-approved label (Zovirax, Bausch Health US, LLC, February 1, 2021) says: “ZOVIRAX Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Acyclovir have a boxed warning?
No. None of the 176 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Acyclovir?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Acyclovir been recalled?
FDA enforcement reports list 9 recalls of products of this medicine; the newest started December 28, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Acyclovir?
66 companies list prescription products of Acyclovir in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and NuCare Pharmaceuticals, Inc..

What Acyclovir is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ZOVIRAX Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. …

— FDA label: Zovirax, Bausch Health US, LLC, effective February 1, 2021. Read the full label on DailyMed →

The FDA has 176 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 176 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Capsule · Ointment · Injection, solution · Suspension · Cream · Injection, powder, lyophilized, for solution
RouteOral · Topical · Intravenous · Cutaneous · Ophthalmic
Prescription products202 in the FDA NDC Directory
Brand namesZovirax, Avaclyr

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Acyclovir, by strength and form
Strength and formGeneric or brandPharmacies pay
acyclovir 200 mg
capsule		 Generic $0.0962 per capsule
acyclovir 200 mg/5 mL
suspension		 Generic $0.0832 per mL
acyclovir 400 mg
tablet		 Generic $0.0955 per tablet
acyclovir 5%
cream		 Generic $8.85 per gram
acyclovir 5%
ointment		 Generic $0.3639–$0.5283 per gram
15 packages, lowest to highest
acyclovir 800 mg
tablet		 Generic $0.1965 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018604
ZOVIRAX		 BauschMarch 29, 1982 17, latest September 29, 2014
2014: Manufacturing (CMC) · 2002: Manufacturing (CMC) · 2001: Labeling
NDA021478
ZOVIRAX		 BauschDecember 30, 2002 4, latest December 23, 2020
2020: Labeling · 2015: Manufacturing (CMC) · 2014: Labeling
NDA202408
AVACLYR		 Fera Pharms LLCMarch 29, 2019 1, latest July 16, 2021
2021: Labeling

Generic approvals (44)

Showing the 40 earliest of 44.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. December 28, 2022 · Class II · Ongoing · D-0095-2023

    Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

    Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20 — Eugia US LLC

  2. September 26, 2022 · Class II · Completed · D-0013-2023

    Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

    Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10. — AuroMedics Pharma LLC

  3. April 21, 2021 · Class III · Terminated · D-0367-2021

    Labeling: Incorrect or Missing Lot and/or Exp Date

    Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle — Heritage Pharmaceuticals Inc

  4. February 18, 2021 · Class I · Terminated · D-0315-2021

    Crystallization: customer complaints for crystallization in finished product.

    Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured — Zydus Pharmaceuticals (USA) Inc

  5. February 18, 2021 · Class I · Terminated · D-0316-2021

    Crystallization: customer complaints for crystallization in finished product.

    Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured — Zydus Pharmaceuticals (USA) Inc

  6. April 25, 2019 · Class II · Terminated · D-1272-2019

    Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

    Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01 — Zydus Pharmaceuticals USA Inc

  7. February 9, 2018 · Class II · Terminated · D-0544-2018

    Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

    Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 — Apace KY LLC

  8. April 27, 2017 · Class III · Terminated · D-0897-2017

    Presence of Foreign Substance: human hair melded into tablet.

    Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC — Hetero USA Inc

  9. July 17, 2013 · Class II · Terminated · D-017-2014

    Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

    Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326. — Apotex Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)141859, 197310, 197311, 197312, 197313, 209977, 307730, 825321, 1734932, 1734934 … (+2)
SPL set ID of the quoted label125dbe4e-94ba-45bd-a714-f9c4b8e8b5c2
FDA labels (SPL)176
FDA applicationsNDA018604, NDA021478, NDA202408, 44 ANDA
Active ingredients (FDA)ACYCLOVIR

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Zovirax, Bausch Health US, LLC, effective February 1, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers