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Ivermectin 10 mg/g Cream — NDC 63629-8754-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ivermectin 10 mg/g Cream — NDC 63629-8754-1 (Billing 63629-8754-01)

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 Oct 2019 and currently FDA-listed. It is this product's only package size.

NDC 63629-8754-01
🏷️ FDA NDC (as labeled) 63629-8754-1 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 →

This page is curated, coded, and maintained by

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 63629-8754-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63629 labeler · 8754 product · 1 package
Package marketed since
Aug 20, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6362987541 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-8754-1
Product NDC 63629-8754
11-digit billing NDC 63629875401
NCPDP billing unit GM — per gram (weight)
RxCUI 1598068
UNII 8883YP2R6D
Application # ANDA210019
SPL Set ID 81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc
Established class (EPC) Antiparasitic; Pediculicide
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-14
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

GPI-14 90060030003720
GPI class Ivermectin
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
  • GPI-14 (Medi-Span): 90060030003720
  • HICL (First Databank): 010933
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 1598068
Why two NDCs? The FDA registers this code as 63629-8754-1 — 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 → 63629-8754-01. 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
63629-8754-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2021-08-20 — 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/gthis 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/g 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA210019 (ANDA)
Labeler code63629
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 63629

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 💊 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

1 INDICATIONS AND USAGE Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream, 1% 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 46 words ▾

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

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

🤒 Adverse Reactions 206 words ▾

6 ADVERSE REACTIONS In controlled clinical trials with ivermectin cream the most common adverse reactions (incidence less than or equal to 1 %) included skin burning sensation and skin irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 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, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily. A total of 1,555 subjects were treated once daily for more than 12 weeks, and 519 for approximately one year.

Adverse reactions, reported in less than or equal to 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 ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Note: The animal multiples of human exposure calculations were based on AUC comparisons. The maximum topical human dose (MTHD) of ivermectin cream is 1 g applied once daily. Systemic embryofetal development studies were conducted in rats and rabbits.

Oral doses of 1.5 mg/kg/day, 4 mg/kg/day, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6 to 17) to pregnant female rats. Maternal death occurred at 12 mg/kg/day (1909X MTHD). Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909X MTHD) group.

No treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708X MTHD). Oral doses of 0.5 mg/kg/day, 1.5 mg/kg/day, 2.5 mg/kg/day, 3.5 mg/kg/day, and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 7 to 20) to pregnant female rabbits. Maternal death occurred at doses greater than or equal to 2.5 mg/kg/day (72X MTHD).

Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354X MTHD) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146X MTHD). No treatment related effects on embryofetal toxicity were noted at 2.5 mg/kg/day (72X MTHD) and no treatment related effects on teratogenicity were noted at 3.5 mg/kg/day (146X MTHD).

A pre- and post-natal development study was conducted in rats. Oral doses of 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6 to 20 and lactation days 2 to 20. Neonatal death occurred at doses greater than or equal to 2 mg/kg/day.

Behavior development of newborn rats was adversely affected at all doses.

8.3Nursing Mothers Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. In oral studies in rats, ivermectin was excreted in the milk of nursing mothers and neonatal toxicity was observed in the litters.

The blood-brain barrier in neonatal rats may not be fully developed at birth. Because of the potential for serious adverse reactions from ivermectin cream in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

8.5Geriatric Use Of the 1,371 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.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Note: The animal multiples of human exposure calculations were based on AUC comparisons. The maximum topical human dose (MTHD) of ivermectin cream is 1 g applied once daily. Systemic embryofetal development studies were conducted in rats and rabbits.

Oral doses of 1.5 mg/kg/day, 4 mg/kg/day, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6 to 17) to pregnant female rats. Maternal death occurred at 12 mg/kg/day (1909X MTHD). Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909X MTHD) group.

No treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708X MTHD). Oral doses of 0.5 mg/kg/day, 1.5 mg/kg/day, 2.5 mg/kg/day, 3.5 mg/kg/day, and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 7 to 20) to pregnant female rabbits. Maternal death occurred at doses greater than or equal to 2.5 mg/kg/day (72X MTHD).

Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354X MTHD) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146X MTHD). No treatment related effects on embryofetal toxicity were noted at 2.5 mg/kg/day (72X MTHD) and no treatment related effects on teratogenicity were noted at 3.5 mg/kg/day (146X MTHD).

A pre- and post-natal development study was conducted in rats. Oral doses of 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6 to 20 and lactation days 2 to 20. Neonatal death occurred at doses greater than or equal to 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 1,371 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 to 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 to 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 to 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 66 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 size: 45 gram – NDC: 63629-8754-1 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. Each gram of ivermectin cream contains 10 mg of ivermectin, USP. It is intended for topical use.

Ivermectin, USP is a semi-synthetic derivative isolated from the fermentation of Streptomyces avermitilis that belongs to the avermectin family of macrocyclic lactones. Ivermectin, USP 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 molecular 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, 1% contains the following inactive ingredients: benzyl alcohol, citric acid anhydrous, carbomer homopolymer type c, di-isopropyl adipate, edetate disodium, hexylene glycol, methylparaben, oleyl alcohol, polysorbate 80, propylparaben, purified water, sodium citrate, sodium hydroxide, and sorbitan tristearate.

💬 Information for Patients 43 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. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Revised – January 2019

🍼 Nursing Mothers 100 words ▾

8.3Nursing Mothers Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. In oral studies in rats, ivermectin was excreted in the milk of nursing mothers and neonatal toxicity was observed in the litters.

The blood-brain barrier in neonatal rats may not be fully developed at birth. Because of the potential for serious adverse reactions from ivermectin cream in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 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 to 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 to 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 to 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 1,371 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 Vehicle Ivermectin Vehicle Cream (N=451) Cream (N=232) Cream (N=459) 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: IGA Success Rates Over Time Figures 3 and 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time

🧪 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 (747X maximum topical human dose (MTHD)). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1 mg/kg/day, 3 mg/kg/day, 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 (1766X MTHD) 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 (1959X MTHD).

No drug-related tumors were noted in males at doses less than or equal to 3 mg/kg/day (599X MTHD). 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 mg/kg/day, 1 mg/kg/day, and 9 mg/kg/day ivermectin were administered to male and female rats.

Mortality occurred at 9 mg/kg/day (1027X MTHD). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses less than or equal to 1 mg/kg/day (68X MTHD).

📄 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 (747X maximum topical human dose (MTHD)). In a 2-year oral rat carcinogenicity study, ivermectin was administered to Wistar rats at gavage doses of 1 mg/kg/day, 3 mg/kg/day, 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 (1766X MTHD) 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 (1959X MTHD).

No drug-related tumors were noted in males at doses less than or equal to 3 mg/kg/day (599X MTHD). 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 mg/kg/day, 1 mg/kg/day, and 9 mg/kg/day ivermectin were administered to male and female rats.

Mortality occurred at 9 mg/kg/day (1027X MTHD). The precoital period was generally prolonged at 9 mg/kg/day. No treatment related effects on fertility or mating performance were noted at doses less than or equal to 1 mg/kg/day (68X MTHD).

📖 Instructions for Use ~1 min read ▾

INSTRUCTION FOR USE Ivermectin (eye" ver mek' tin) Cream, 1% Important: Ivermectin cream is for use on the face only. Do not use ivermectin cream in your eyes, mouth or vagina. Read and follow the steps below so that you use ivermectin cream correctly: 1.

Open the tube of ivermectin cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise) as shown below. See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.

Figure A Figure B 2. To apply ivermectin cream to your face, squeeze a pea-sized amount of ivermectin cream from the tube onto your fingertip. See Figure C.

Figure C 3. Apply ivermectin to the affected areas of your face once a day. Use a pea-sized amount of ivermectin cream for each area of your face (forehead, chin, nose, each cheek) that is affected.

Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips. 4.

To close ivermectin cream, gently press down on the child resistant cap and twist to the right (clockwise). See Figure D. Figure D 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 out of the reach of children. This Instructions for Use has been approved by the U.S.

Food and Drug Administration. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Revised – January 2019

📄 Package Label / Principal Display Panel 6 words ▾

Ivermectin 10 mg/g 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 ✓ Available
Inactive ingredients (structured) ✓ 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.
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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.