Prescription medicine
Acyclovir Brand names: Zovirax, Avaclyr
Acyclovir (Zovirax) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 66 generic labelers, and pharmacies paid $0.0962 per acyclovir 400 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the acyclovir FDA label on DailyMed (effective July 24, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 18604 record on Drugs@FDA; every acyclovir label on DailyMed.
Highlights of the record
FDA label of July 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageHerpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles).
Forms and strengths
- 1 g
- 200 mg
- 400 mg
- 500 mg
- 800 mg
- 30 mg/g
- 50 mg/g
- 50 mg/ml
- 200 mg/5ml
- 500 mg/10ml
- 1000 mg/20ml
Tablet; capsule; ointment; injection (solution); suspension.
On the market
- Earliest approval on file
- March 29, 1982 Zovirax, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 88 first April 22, 1997; 46 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 69 of which 66 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 16, 2030 Sitavig tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0962 per tablet Acyclovir 400 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 12 since 2013 2 Class I among all firms' recalls; latest February 5, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 114,717 through July 30, 2026
What is acyclovir used for?
From the label: indications and usageHerpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).
Conditions named in the indications of acyclovir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor and Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor.
Source: FDA drug label (ACYCLOVIR), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 24, 2026 (SPL set 0de2f5c7-9e75-4bdf-9c28-e026cc6694b4), via openFDA; the full label on DailyMed
Is there a generic for acyclovir (Zovirax)?
The FDA approved the first generic acyclovir on April 22, 1997. 88 generic applications are approved; 46 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acyclovir from 66 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zovirax ointment; a patent listed only for Sitavig tablets runs to June 16, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1982 earliest approval on file
- 1997 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acyclovir (Zovirax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0962 per Acyclovir 400 mg tablet, up 5% from $0.0913 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acyclovir 400 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acyclovir 200 mg capsule | Generic | $0.0977 per capsule | $2.93 | -6% |
| Acyclovir 200 mg/5 mL suspension | Generic | $0.0764 per mL | n/a | -12% |
| Acyclovir 400 mg tablet | Generic | $0.0962 per tablet | $2.89 | +5% |
| Acyclovir 5% cream | Generic | $8.99 per gram | n/a | -20% |
| Acyclovir 5% ointment | Generic | $0.346 per gram | n/a | -16% |
| Acyclovir 800 mg tablet | Generic | $0.194 per tablet | $5.82 | +20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acyclovir been recalled?
The FDA's Enforcement Report lists 15 recalls naming acyclovir since 2013: 2 Class I (the most serious), 10 Class II, 3 Class III; 3 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of acyclovir and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 5, 2026 | Class II | Fresenius Kabi Compounding, LLC | Lack of Assurance of Sterility |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| December 28, 2022 | Class II | Eugia US LLC | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial |
| September 26, 2022 | Class II | AuroMedics Pharma LLC | Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. |
| April 21, 2021 | Class III | Heritage Pharmaceuticals Inc | Labeling: Incorrect or Missing Lot and/or Exp Date |
| February 18, 2021 | Class I | Zydus Pharmaceuticals (USA) Inc | Crystallization: customer complaints for crystallization in finished product. |
| April 25, 2019 | Class II | 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 |
| February 9, 2018 | Class II | Apace KY LLC | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acyclovir label say about other medicines?
The acyclovir label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 25 other medicines name acyclovir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Valacyclovir | contraindications | CONTRAINDICATIONS Acyclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to acyclovir, valacyclovir, or any component of the formulation (see WARNINGS and ADVERSE REACTIONS ). |
Other labels that name acyclovir
Source: FDA drug label (ACYCLOVIR), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 24, 2026 (SPL set 0de2f5c7-9e75-4bdf-9c28-e026cc6694b4), via openFDA; the full label on DailyMed
What do FAERS reports show for acyclovir?
The FDA Adverse Event Reporting System holds 114,717 reports that list acyclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,660 are coded as a death and 42,629 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acyclovir?
2 other medicines are given the same way (oral) and in the same FDA class as acyclovir or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Valacyclovir | Herpes and shingles | 40 labelers | $0.229 per tablet 500 mg tablet | No current entry |
| Famciclovir | Herpes and shingles | 9 labelers | $0.214 per tablet 125 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does acyclovir compare with medicines for the same use?
2 side-by-side pages set acyclovir beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other herpes simplex virus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Acyclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other