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Ivermectin 10 mg/g Cream — NDC 71335-2946-1 (Billing 71335-2946-01)

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON / 45 g in 1 TUBE

This is a package of Ivermectin 10 mg/g Cream from Bryant Ranch Prepack, marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 71335-2946-01
🏷️ FDA NDC (as labeled) 71335-2946-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 71335-2946-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71335 labeler · 2946 product · 1 package
Package marketed since
Oct 23, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7133529461 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71335-2946-1
Product NDC 71335-2946
11-digit billing NDC 71335294601
NCPDP billing unit GM — per gram (weight)
RxCUI 1598068
UNII 8883YP2R6D
Application # ANDA210225
SPL Set ID 1061e454-d1dc-4293-b18d-9c8717fbbb40
Established class (EPC) Antiparasitic; Pediculicide
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-08
Route TOPICAL
Dosage form CREAM
Substance IVERMECTIN
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 073235
GCN 37612
HICL code 010933
Ingredient (HICL) Ivermectin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name IVERMECTIN 1% CREAM
FDB brand name Ivermectin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073235
  • GCN: 37612
  • HICL (First Databank): 010933
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 1598068
Why two NDCs? The FDA registers this code as 71335-2946-1 — a 5-4-1 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 package segment → 71335-2946-01. 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 Antiparasitic class.

Pharmacologic class Antiparasitic, Pediculicide
Drug family (ATC) Other dermatologicals, Avermectines
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 IVERMECTIN 1% CREAM Ingredient Ivermectin
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets treat intestinal strongyloidiasis and onchocerciasis. Lotions treat head lice, and the cream treats the bumps and pimples of rosacea.
  • Stromectol and ivermectin tablets are usually a single dose based on your weight. Take it on an empty stomach with water. Your doctor may order follow-up stool tests to confirm the...
  • Apply it to dry hair and scalp, covering everything from the scalp outward. Leave it on for 10 minutes, then rinse with water only. Wait 24 hours before shampooing, and don't reuse...
  • Dizziness, itching, rash, nausea, diarrhea, and tiredness were reported. If you're treated for onchocerciasis, fever, swollen glands, and joint pain can happen as the parasites die...
📖 Read our full Ivermectin 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $7.33 $329.83 / 45 g
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 Marketing startMarketing endStatus
71335-2946-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2025-10-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ivermectin 10 mg/g 00591-4052-89 Actavis 1 tube $2.746 AB Availability likely —
Ivermectin 10 mg/g 45802-0102-84 Padagis 1 tube $2.746 AB Availability likely —
Ivermectin 10 mg/g 68308-0701-45 Mayne 1 tube $2.746 AB Availability likely —
Soolantra 10 mg/g 00299-3823-00 Galderma 2 g — AB FDA listed —
Ivermectin 10 mg/g 63629-8754-01 Bryant 1 tube — AB FDA listed —
ivermectin 10 mg/g 70771-1728-02 Zydus 1 tube — AB FDA listed —
Ivermectin 10 mg/gthis 71335-2946-01 Bryant 1 tube — AB FDA listed —
Ivermectin 10 mg/g 72162-2294-02 Bryant 1 tube — AB FDA listed —
ivermectin 10 mg/g 72578-0120-02 Viona 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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.

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

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA210225 (ANDA)
Labeler code71335
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 71335

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

1 INDICATIONS AND USAGE Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )

⏱️ Dosage and Administration 72 words ▾

2 DOSAGE AND ADMINISTRATION Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. Ivermectin cream is not for oral, ophthalmic, or intravaginal use. Apply to the affected areas once daily. ( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 1%. Each gram of ivermectin cream contains 10 mg of ivermectin in a white to pale yellow cream base. Ivermectin cream is supplied in tubes of 30 g, 45 g and 60 g. Cream, 1% ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

🤒 Adverse Reactions 194 words ▾

6 ADVERSE REACTIONS In controlled clinical trials with ivermectin cream the most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 2047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily. A total of 1555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.

Adverse reactions, reported in ≤ 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.

6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local adverse reactions: contact dermatitis and allergic dermatitis.

🔄 Drug Interactions 22 words ▾

7 DRUG INTERACTIONS In vitro studies have shown that ivermectin cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively. These orally administered doses were maternally toxic to pregnant rats and rabbits.

In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data No adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. Retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural Africa.

In an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. When compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. These studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester.

Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. Maternal death occurred at 12 mg/kg/day [1909 times the MRHD based on area under the curve (AUC) comparison].

Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the MRHD based on AUC comparison) group. No treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the MRHD based on AUC comparison). Oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits.

Maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the MRHD based on AUC comparison) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146 times the MRHD based on AUC comparison).

No treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). A pre- and postnatal development study was conducted in rats. Oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6-20 and lactation days 2-20.

Neonatal death occurred at doses ≥ 2 mg/kg/day. Behavior development of newborn rats was adversely affected at all doses.

8.2Lactation Risk Summary The presence of ivermectin in human milk following topical administration of ivermectin has not been evaluated. There are no data available regarding the effects of ivermectin on milk production. Published literature suggests that ivermectin was detectable in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. However, th… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data on the use of ivermectin, including ivermectin cream, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant rats and rabbits during the period of organogenesis at doses 1909 or 354 times the maximum recommended human dose (MRHD), respectively. These orally administered doses were maternally toxic to pregnant rats and rabbits.

In a pre-and postnatal developmental study in rats, neonatal toxicity and adverse effects on behavioral development were observed when ivermectin was orally administered to pregnant females during gestation and lactation ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data No adequate and well-controlled trials of ivermectin cream have been conducted in pregnant women. Retrospective observational studies evaluated pregnancy outcomes in over 700 women in various stages of pregnancy who received oral ivermectin for the treatment of soil-transmitted helminths in rural Africa.

In an additional, randomized open-label trial, 397 pregnant women in their second trimester received a single dose of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths. When compared with a pregnant, untreated population, no differences in pregnancy outcomes were observed between the treated and untreated populations. These studies cannot definitively establish or exclude any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester.

Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1.5, 4, and 12 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rats. Maternal death occurred at 12 mg/kg/day [1909 times the MRHD based on area under the curve (AUC) comparison].

Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909 times the MRHD based on AUC comparison) group. No treatment related embryofetal toxicity or malformations were noted at 4 mg/kg/day (708 times the MRHD based on AUC comparison). Oral doses of 0.5, 1.5, 2.5, 3.5 and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis to pregnant female rabbits.

Maternal death occurred at doses ≥ 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354 times the MRHD based on AUC comparison) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146 times the MRHD based on AUC comparison).

No treatment related embryofetal toxicity or malformations were noted at 2.5 mg/kg/day (72 times the MRHD based on AUC comparison). A pre- and postnatal development study was conducted in rats. Oral doses of 1, 2 and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6-20 and lactation days 2-20.

Neonatal death occurred at doses ≥ 2 mg/kg/day. Behavior development of newborn rats was adversely affected at all doses.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of ivermectin cream in pediatric patients have not been established.

🧓 Geriatric Use 72 words ▾

8.5Geriatric Use Of the 1371 subjects in the two pivotal clinical studies of ivermectin cream, 170 (12.4%) were 65 and over, while 37 (2.7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 124 words ▾

10 OVERDOSAGE In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects have been reported most frequently: rash, edema, headache, dizziness, asthenia, nausea, vomiting, and diarrhea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain, paresthesia, urticaria, and contact dermatitis. In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if clinically significant hypotension is present.

Induction of emesis and/or gastric lavage as soon as possible, followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent absorption of ingested material.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of ivermectin cream in treating rosacea lesions is unknown.

12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic doses, ivermectin cream is not expected to prolong QTc interval.

12.3Pharmacokinetics Absorption The absorption of ivermectin from ivermectin cream was evaluated in a clinical trial in 15 adult male and female subjects with severe papulopustular rosacea applying 1 g ivermectin cream, 1% once daily. At steady state (after 2 weeks of treatment), the highest mean ± standard deviation plasma concentrations of ivermectin peaked (T max ) at 10 ± 8 hours post-dose, the maximum concentration (C max ) was 2.10 ± 1.04 ng/mL (range: 0.69 - 4.02 ng/mL) and the area under the concentration curve (AUC 0-24hr ) was 36.14 ± 15.56 ng.hr/mL (range: 13.69-75.16 ng.hr/mL).

In addition, systemic exposure assessment in longer treatment duration (Phase 3 studies) showed that there was no plasma accumulation of ivermectin over the 52-week treatment period. Distribution An in vitro study demonstrated that ivermectin is greater than 99% bound to plasma proteins and is bound primarily to human serum albumin. No significant binding of ivermectin to erythrocytes was observed.

Metabolism In vitro studies using human hepatic microsomes and recombinant CYP450 enzymes have shown that ivermectin is primarily metabolized by CYP3A4. In vitro studies show that ivermectin at therapeutic concentrations does not inhibit the CYP450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or 4A11, or induce 1A2, 2B6, 2C9 or 3A4. Excretion The apparent terminal half-life averaged 6.5 days (mean ± standard deviation: 155 ± 40 hours, range 92-238 hours) in patients receiving a once daily cutaneous application of ivermectin cream for 28 days.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action The mechanism of action of ivermectin cream in treating rosacea lesions is unknown.

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ivermectin Cream, 1% is a white to pale yellow cream, supplied in a laminated tube with a child resistant cap in the following sizes: 45 g NDC 71335-2946-1 Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description ~1 min read ▾

11 DESCRIPTION Ivermectin Cream, 1% is a white to pale yellow hydrophilic cream intended for topical use. Each gram of ivermectin cream contains 10 mg of ivermectin. Ivermectin is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones.

Ivermectin is a mixture containing not less than 95.0 % and not more than 102.0 % of 5-O-demethyl-22,23-dihydroavermectin A 1a plus 5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)-22,23-dihydroavermectin A 1a , generally referred to as 22,23-dihydroavermectin B 1a and B 1b or H 2 B 1a and H 2 B 1b , respectively; and the ratio (calculated by area percentage) of component H 2 B 1a /(H 2 B 1a + H 2 B 1b ) is not less than 90.0 %. The respective empirical formulas of H 2 B 1a and H 2 B 1b are C 48 H 74 O 14 and C 47 H 72 O 14 with molecular weights of 875.10 and 861.07 respectively.

The structural formulas are: Component H 2 B 1a : R = C 2 H 5 , Component H 2 B 1b : R = CH 3 . Ivermectin cream contains the following inactive ingredients: cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. formula

💬 Information for Patients 44 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Patients using ivermectin cream should receive the following instruction: Keep out of reach of children. Manufactured by Padagis ® , Yeruham, Israel www.padagis.com Rev 03-24 3Y100 RC PH4

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption The absorption of ivermectin from ivermectin cream was evaluated in a clinical trial in 15 adult male and female subjects with severe papulopustular rosacea applying 1 g ivermectin cream, 1% once daily. At steady state (after 2 weeks of treatment), the highest mean ± standard deviation plasma concentrations of ivermectin peaked (T max ) at 10 ± 8 hours post-dose, the maximum concentration (C max ) was 2.10 ± 1.04 ng/mL (range: 0.69 - 4.02 ng/mL) and the area under the concentration curve (AUC 0-24hr ) was 36.14 ± 15.56 ng.hr/mL (range: 13.69-75.16 ng.hr/mL).

In addition, systemic exposure assessment in longer treatment duration (Phase 3 studies) showed that there was no plasma accumulation of ivermectin over the 52-week treatment period. Distribution An in vitro study demonstrated that ivermectin is greater than 99% bound to plasma proteins and is bound primarily to human serum albumin. No significant binding of ivermectin to erythrocytes was observed.

Metabolism In vitro studies using human hepatic microsomes and recombinant CYP450 enzymes have shown that ivermectin is primarily metabolized by CYP3A4. In vitro studies show that ivermectin at therapeutic concentrations does not inhibit the CYP450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or 4A11, or induce 1A2, 2B6, 2C9 or 3A4. Excretion The apparent terminal half-life averaged 6.5 days (mean ± standard deviation: 155 ± 40 hours, range 92-238 hours) in patients receiving a once daily cutaneous application of ivermectin cream for 28 days.

🧬 Pharmacodynamics 16 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At therapeutic doses, ivermectin cream is not expected to prolong QTc interval.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES Ivermectin cream applied once daily at bedtime was evaluated in the treatment of inflammatory lesions of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trials were conducted in 1371 subjects aged 18 years and older who were treated once daily for 12 weeks with either ivermectin cream or vehicle cream. Overall, 96% of subjects were Caucasian and 67% were female.

Using the 5-point Investigator Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79% of subjects were scored as moderate (IGA=3) and 21% scored as severe (IGA= 4) at baseline. The co-primary efficacy endpoints in both pivotal trials were the success rate based on the IGA outcome (percentage of subjects “clear” and “almost clear”) and absolute change from baseline in inflammatory lesion counts at Week 12. Table 1 presents the co-primary efficacy results at Week 12.

Ivermectin cream was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both studies, see Figures 1 through 4. Table 1: Co-Primary Efficacy Results at Week 12 Study 1 Study 2 Ivermectin Cream (N=451) Vehicle Cream (N=232) Ivermectin Cream (N=459) Vehicle Cream (N=229) Investigator Global Assessment: Number (%) of Subjects Clear or Almost Clear 173 (38.4%) 27 (11.6%) 184 (40.1%) 43 (18.8%) Inflammatory Lesion Counts: Mean Absolute (%) Change from Baseline 20.5 (64.9%) 12.0 (41.6%) 22.2 (65.7%) 13.4 (43.4%) figures 1 and 2 figures 3 and 4

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal mouse carcinogenicity study, ivermectin was administered to CD-1 mice at topical doses of 1, 3, and 10 mg/kg/day (0.1%, 0.3% and 1% ivermectin cream applied at 2 ml/kg/day). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 10 mg/kg/day (747 times the MRHD based on AUC comparison). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1, 3, and 9 mg/kg/day.

A statistically significant increase in the incidence of hepatocellular adenoma was noted in males treated with 9 mg/kg/day (1766 times the MRHD based on AUC comparison) ivermectin. The clinical relevance of this finding is unknown. No drug-related tumors were noted in females up to the highest dose evaluated in this study of 9 mg/kg/day (1959 times the MRHD based on AUC comparison).

No drug-related tumors were noted in males at doses ≤ 3 mg/kg/day (599 times the MRHD based on AUC comparison). Ivermectin revealed no evidence of genotoxic potential based on the results of two in vitro genotoxicity tests (the Ames test and the L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (rat micronucleus assay). In a fertility study, oral doses of 0.1, 1 and 9 mg/kg/day ivermectin were administered to male and female rats.

Mortality occurred at 9 mg/kg/day (1027 times the MRHD based on AUC comparison). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses ≤ 1 mg/kg/day (68 times the MRHD based on AUC comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year dermal mouse carcinogenicity study, ivermectin was administered to CD-1 mice at topical doses of 1, 3, and 10 mg/kg/day (0.1%, 0.3% and 1% ivermectin cream applied at 2 ml/kg/day). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 10 mg/kg/day (747 times the MRHD based on AUC comparison). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1, 3, and 9 mg/kg/day.

A statistically significant increase in the incidence of hepatocellular adenoma was noted in males treated with 9 mg/kg/day (1766 times the MRHD based on AUC comparison) ivermectin. The clinical relevance of this finding is unknown. No drug-related tumors were noted in females up to the highest dose evaluated in this study of 9 mg/kg/day (1959 times the MRHD based on AUC comparison).

No drug-related tumors were noted in males at doses ≤ 3 mg/kg/day (599 times the MRHD based on AUC comparison). Ivermectin revealed no evidence of genotoxic potential based on the results of two in vitro genotoxicity tests (the Ames test and the L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (rat micronucleus assay). In a fertility study, oral doses of 0.1, 1 and 9 mg/kg/day ivermectin were administered to male and female rats.

Mortality occurred at 9 mg/kg/day (1027 times the MRHD based on AUC comparison). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses ≤ 1 mg/kg/day (68 times the MRHD based on AUC comparison).

📄 Patient Package Insert ~3 min read ▾

Patient Information PATIENT INFORMATION Ivermectin (eye-ver-MEK-tin) Cream, 1% Important: Ivermectin cream is for use on the skin only (topical use) . Do not use ivermectin cream in your mouth, eyes, or vagina. What is ivermectin cream?

Ivermectin cream is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if ivermectin cream is safe and effective in children. Before using ivermectin cream, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if ivermectin cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ivermectin passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ivermectin cream. are breastfeeding or plan to breastfeed.

It is not known if ivermectin passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ivermectin cream. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ivermectin cream? See the detailed “Instructions for Use” that comes with ivermectin cream for information on how to apply ivermectin cream. Use ivermectin cream exactly as your healthcare provider tells you to.

Apply ivermectin cream to the affected areas of your face 1 time a day. Avoid contact with your eyes and lips. If ivermectin cream is accidentally swallowed (ingested), call your healthcare provider or go to the nearest hospital emergency room right away.

Apply ivermectin cream to the affected areas of your face 1 time a day. Avoid contact with your eyes and lips. If ivermectin cream is accidentally swallowed (ingested), call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of ivermectin cream? The most common side effects of ivermectin cream include skin burning sensation and skin irritation. These are not all of the possible side effects of ivermectin cream.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Padagis ® at 1-866-634-9120.

How should I store ivermectin cream? Store ivermectin cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep ivermectin cream and all medicines out of the reach of children.

General information about the safe and effective use of ivermectin cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ivermectin cream for a condition for which it was not prescribed.

Do not give ivermectin cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ivermectin cream that is written for health professionals.

What are the ingredients in ivermectin cream? Active ingredient: ivermectin Inactive ingredients: cetyl alcohol, citric acid monohydrate, dimethicone, edetate disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol, phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-24 For more information about ivermectin cream call 1-866-634-9120.

This Patient Information has been approved by the U.S. Food and Drug Administration.

📄 Package Label / Principal Display Panel 5 words ▾

Ivermectin 1% Cream #45 Label

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

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

Medicare Part D (outpatient prescription) spending for IVermectin — the program that covers self-administered drugs. 7 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 IVermectin. 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
$3.22M
Claims incl. refills
25.2K
Beneficiaries
20.3K
Spend / beneficiary
$158.78
Spend / claim
$128.08
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71335-2945-01 · Bryant 71335-2947-01 · Bryant →
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.