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Acyclovir 50 mg/g Ointment — NDC 65162-835-94 (Billing 65162-0835-94)

by Amneal Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Acyclovir 50 mg/g Ointment from Amneal Pharmaceuticals LLC, marketed since Jan 2014 and currently FDA-listed; retail pharmacies pay about $0.5221 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 65162-0835-94
🏷️ FDA NDC (as labeled) 65162-835-94 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.5221 NADAC Per package$7.83 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.35/unit · Part D plans $1.40/unit — full pricing hub ↓
Main listing for product 65162-835 · Also comes in: 30 g 65162-835-96
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65162-835-94
Product NDC 65162-835
11-digit billing NDC 65162083594
NCPDP billing unit GM — per gram (weight)
RxCUI 197312
UNII X4HES1O11F
UPC 0365162835946, 0365162835960
Application # ANDA204605
SPL Set ID 269e2203-347d-40dc-b794-11cf34690f27
Established class (EPC) Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of action DNA Polymerase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-03
Route TOPICAL
Dosage form OINTMENT
Substance ACYCLOVIR
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90350010004205
GPI class Acyclovir
GCN Seq No 007670
GCN 31640
HICL code 004183
Ingredient (HICL) Acyclovir
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5V
Therapeutic class — specific (HIC3) Topical Antivirals
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name ACYCLOVIR 5% OINTMENT
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007670
  • GCN: 31640
  • GPI-14 (Medi-Span): 90350010004205
  • HICL (First Databank): 004183
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 197312
Why two NDCs? The FDA registers this code as 65162-835-94 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65162-0835-94. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Antivirals
How it works DNA Polymerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACYCLOVIR 5% OINTMENT Ingredient Acyclovir
📗 Our plain-language guide HelloPharmacist
  • Acyclovir treats infections caused by herpes-family viruses. Oral forms treat shingles, genital herpes and chickenpox. Creams, ointments, the eye ointment, the buccal tablet and th...
  • As early as possible. For cold sores, that means at the first tingling, itching or burning. For genital herpes recurrences, start at the first sign of an outbreak. Early treatment...
  • The most common ones are headache, nausea and belly pain. Some people also get vomiting, dizziness or fatigue. These are usually manageable, but tell me if they bother you.
  • Call right away for confusion, hallucinations, seizures or unusual drowsiness. Also call if you urinate much less than usual, which can signal kidney trouble. Any allergic reaction...
📖 Read our full Acyclovir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.522 $7.83 / 15 g
Medicaid paysCMS SDUD · 12 mo $1.35 $20.31 / 15 g
Medicare drug plans payPart D · Q2 2026 $1.40 $21.00 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.369 $0.515
▼ Down 47% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
65162-0835-94 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.5221 / g $7.83 2014-01-03 — Active
65162-0835-96 65162-835-96 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.3459 / g $10.38 2014-01-03 — Active

Per g, this pack runs about 51% above the cheapest pack (NDC 65162-0835-96, $0.3459 vs $0.5221 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 84% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Acyclovir 50 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 50 mg/g 00591-1159-30 ACTAVIS 1 tube $0.315 AB Availability likely save 40%
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.522 AB Availability likely —
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/gthis 65162-0835-94 Amneal 1 tube $0.522 AB Availability likely —
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.522 AB Availability likely —
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed +29%
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $8.992 AB Availability likely +1622%
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $8.992 AB Availability likely +1622%
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $8.992 AB Availability likely +1622%
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $8.992 AB Availability likely +1622%
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $8.992 AB Availability likely +1622%
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed +7225%
Zovirax 50 mg/g 00187-0993-95 Bausch 1 tube — AB FDA listed —
Acyclovir 50 mg/g 43547-0499-41 Solco 1 tube — — FDA listed —
acyclovir 50 mg/g 50090-6561-00 A-S 1 tube — AB FDA listed —
Acyclovir 50 mg/g 62332-0248-05 Alembic 1 tube — AB FDA listed —
Acyclovir 50 mg/g 63629-2327-01 Bryant 30 g — AB FDA listed —
Acyclovir 50 mg/g 63629-2328-01 Bryant 15 g — AB FDA listed —
acyclovir 50 mg/g 68071-3909-05 NuCare 1 tube — AB FDA listed —
acyclovir 50 mg/g 68788-8247-01 Preferred 1 tube — AB FDA listed —
acyclovir 50 mg/g 70771-1371-01 Zydus 1 tube — AB FDA listed —
Acyclovir 50 mg/g 72162-1960-02 Bryant 15 g — AB FDA listed —
acyclovir 50 mg/g 85766-0115-15 Sportpharm 1 tube — AB FDA listed —
Acyclovir 50 mg/g 85957-0036-01 Aryeh 2 tubes — AB FDA listed —
Acyclovir 50 mg/g 72162-2327-02 Bryant 1 tube — AB FDA listed —
Acyclovir 50 mg/g 70771-1808-02 Zydus 1 tube — BX FDA listed —
Acyclovir 50 mg/g 72578-0101-04 Viona 1 tube — BX FDA listed —
acyclovir 50 mg/g 68788-4142-01 c 15 g — AB FDA listed —
acyclovir 50 mg/g 50090-8074-00 A-S 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA204605 (ANDA)
Labeler code65162
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio490 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

⏱️ Dosage and Administration 92 words ▾

DOSAGE AND ADMINISTRATION Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment 5% to prevent autoinoculation of other body sites and transmission of infection to other persons.

Therapy should be initiated as early as possible following onset of signs and symptoms.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

⚠️ Warnings 18 words ▾

WARNINGS Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.

🤒 Adverse Reactions 152 words ▾

ADVERSE REACTIONS In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.

Observed During Clinical Practice: Based on clinical practice experience in patients treated with acyclovir ointment 5% in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process.

Voluntary reports of adverse events that have been received since market introduction include: General: Edema and/or pain at the application site. Skin: Pruritus, rash.

🆘 Overdosage 20 words ▾

OVERDOSAGE Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous Herpes simplex virus infections or with localized varicella-zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In 1 of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches.

No local intolerance, systemic toxicity, or contact dermatitis were observed. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL). The other study included 11 patients with localized varicella-zoster infections.

In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Acyclovir levels in plasma ranged from <0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from <0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose.

Therefore, systemic absorption of acyclovir after topical application is minimal. Clinical Trials In clinical trials of initial genital herpes infections, acyclovir ointment 5% has shown a decrease in healing time and, in some cases, a decrease in duration of viral shedding and duration of pain. In studies in immunocompromised patients mainly with herpes labialis, there was a decrease in duration of viral shedding and a slight decrease in duration of pain.

In studies of recurrent genital herpes and of herpes labialis in nonimmunocompromised patients, there was no evidence of clinical benefit; there was some decrease in duration of viral shedding.

📦 How Supplied / Storage and Handling 70 words ▾

HOW SUPPLIED Acyclovir Ointment, USP 5% is supplied as a white color ointment. Each gram of acyclovir ointment, USP 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 15-g tubes (NDC 65162-835-94) 30-g tubes (NDC 65162-835-96) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 02-2016-01

📋 Description ~2 min read ▾

DESCRIPTION Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base.

Acyclovir, USP is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25.

The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: VIROLOGY Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue.

The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro , acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase.

The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors.

Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL.

Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated.

TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. eae4daa9-figure-01

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION ). There are no data to support the use of acyclovir ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. Acyclovir ointment 5% should not be used for the prevention of recurrent HSV infections.

Although clinically significant viral resistance associated with the use of acyclovir ointment 5% has not been observed, this possibility exists. Drug Interactions: Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%. Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic exposure following topical administration of acyclovir is minimal.

Dermal carcinogenicity studies were not conducted. Results from the studies of carcinogenesis, mutagenesis, and fertility are not included in the full prescribing information for acyclovir ointment 5% due to the minimal exposures of acyclovir that result from dermal application. Information on these studies is available in the full prescribing information for acyclovir capsules, tablets, and suspension and acyclovir for injection.

Pregnancy: Teratogenic Effects: Pregnancy Category B. Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women.

A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population.

However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether topically applied acyclovir is excreted in breast milk.

Systemic exposure following topical administration is minimal. After oral administration of acyclovir, acyclovir concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg per day.

Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing. Geriatric Use: Clinical studies of acyclovir ointment 5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY ). Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

📄 Package Label / Principal Display Panel 20 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.9K
Units reimbursed last 4 qtrs
121.3K
Gross reimbursed last 4 qtrs
$164.3K
Avg / prescription
$23.97
Avg / unit
$1.3540
Latest quarter Q1 2026
1.9KRx
Medicaid pays / g
$1.3540
gross reimbursed
vs
NADAC / g
$0.5221
acquisition cost
=
Spread
+$0.8319
+159% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 2,634 Rx Managed care · 4,219 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 720 units · 36.7 per 100k residents ID Montana: 870 units · 76.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,305 units · 22.7 per 100k residents MN Wisconsin: 2,040 units · 34.5 per 100k residents WI Michigan: 6,965 units · 69.4 per 100k residents MI New York: 6,260 units · 32.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,080 units · 25.5 per 100k residents OR Nevada: 1,380 units · 43.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 240 units · 1.9 per 100k residents IL Indiana: 300 units · 4.4 per 100k residents IN Ohio: 6,440 units · 54.6 per 100k residents OH Pennsylvania: 7,735 units · 59.7 per 100k residents PA New Jersey: 3,045 units · 32.8 per 100k residents NJ Massachusetts: 1,785 units · 25.5 per 100k residents MA California: 16,448 units · 42.2 per 100k residents CA Utah: 900 units · 26.3 per 100k residents UT Colorado: 2,520 units · 42.9 per 100k residents CO Nebraska: no data reported NE Missouri: 4,305 units · 69.5 per 100k residents MO Kentucky: 6,167 units · 136 per 100k residents KY West Virginia: 3,015 units · 170 per 100k residents WV Virginia: 6,165 units · 70.7 per 100k residents VA Maryland: 2,385 units · 38.6 per 100k residents MD Connecticut: 2,820 units · 78.0 per 100k residents CT Rhode Island: 180 units · 16.4 per 100k residents RI Arizona: 1,155 units · 15.5 per 100k residents AZ New Mexico: 1,260 units · 59.6 per 100k residents NM Kansas: 870 units · 29.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 3,705 units · 52.0 per 100k residents TN North Carolina: 7,830 units · 72.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 1,740 units · 42.9 per 100k residents OK Louisiana: 6,675 units · 146 per 100k residents LA Mississippi: 255 units · 8.7 per 100k residents MS Alabama: 2,625 units · 51.4 per 100k residents AL Georgia: 1,785 units · 16.2 per 100k residents GA D.C.: 180 units · 26.5 per 100k residents DC Hawaii: no data reported HI Texas: 1,380 units · 4.5 per 100k residents TX Florida: 6,810 units · 30.1 per 100k residents FL
Units reimbursed · per 100k residents
1.9170
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 170 /100k
2 Louisiana 146 /100k
3 Kentucky 136 /100k
4 Connecticut 78.0 /100k
5 Montana 76.9 /100k
6 North Carolina 72.3 /100k
7 Virginia 70.7 /100k
8 Missouri 69.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page65162-0835-94 6,853 Rx · $164,290
1 tube65162-0835-96 1,280 Rx · $75,174
Drug total (last 4 qtrs): 8,133 Rx · 162,815 units · $239,464 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acyclovir — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acyclovir. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.1M
Claims incl. refills
517.4K
Beneficiaries
366.8K
Spend / beneficiary
$30.28
Spend / claim
$21.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 65162-0826-34 · Amneal 65162-0836-14 · Amneal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.