Who Makes the Ivermectin Tablets Sold in the US?

Oral ivermectin tablets sold in the US come from two kinds of source: Stromectol, the original brand made by Merck, and FDA-approved generic versions labeled "ivermectin tablets USP." Both brand and generic are 3mg tablets, and both are prescription medicines under federal law. We don't sell either. The tablets we sell, Iverheal, are made in India by Healing Pharma, aren't FDA-approved, and are supplied only against a valid prescription. More on where they fit below.

This guide explains who stands behind the tablets on a US pharmacy shelf, what the letters "USP" mean, how a generic is held to the brand's standard, and why imported and veterinary products aren't the same thing.

Who makes Stromectol?

Stromectol is Merck's brand of ivermectin. It was the first oral ivermectin approved by the FDA for people, and it's approved for two parasitic worm infections: strongyloidiasis of the intestinal tract and onchocerciasis. In the US it comes as a 3mg tablet.

Because Stromectol was first, its approval is the reference that every generic is compared against. Our article on Stromectol vs generic ivermectin compares the two side by side.

Who makes generic ivermectin tablets?

After a brand's exclusivity ends, other companies can apply to the FDA to sell a generic version. Edenbridge Pharmaceuticals is one company that has held an FDA approval for generic ivermectin 3mg tablets.

Other companies may hold approvals too, and the list can change over time. Rather than rely on a list that goes out of date, you can check the FDA's own records, which we explain further down.

One detail trips people up. The company named most prominently on a carton is the one that holds the approval or markets the product. A separate "Manufactured by" or "Made in" line sometimes names the plant that actually produced the tablets. Both are normal. The company holding the approval is responsible for the product meeting FDA standards wherever it's made.

What does "USP" on the label mean?

USP stands for the United States Pharmacopeia, an independent, nonprofit organization that publishes official quality standards for medicines. When a label says "Ivermectin Tablets USP," it means the product is meant to meet the USP standard for that medicine. The standard covers things like:

• Identity: the tablet contains ivermectin and not something else.
• Strength: the amount of ivermectin matches the label, within set limits.
• Purity: impurities stay below set levels.
• Performance: the tablet dissolves the way it should.

US law recognizes these standards, and the FDA can enforce them. "USP" isn't a brand or a seal you buy. It's a reference to a public standard.

Is a generic as good as the brand?

The FDA requires an approved generic to have the same active ingredient, strength, dosage form and route as the brand. The company must also show the generic is bioequivalent, meaning it delivers the active ingredient into the body in the same amount and at the same rate, within tight limits. Generic makers' plants are inspected to the same manufacturing standards as brand makers'.

What can differ is everything else: the tablet's color, shape and markings, the inactive ingredients, the packaging and, usually, the price. If you have an allergy to a dye or filler, ask the pharmacist to check the inactive ingredients on the specific product.

| | Stromectol (brand) | Generic ivermectin USP | |---|---|---| | Made by | Merck | Approved generic makers, e.g. Edenbridge | | Active ingredient | Ivermectin | Ivermectin | | US tablet strength | 3mg | 3mg | | FDA-approved | Yes | Yes, as a generic | | Prescription status | Prescription-only (federal) | Prescription-only (federal) | | Inactive ingredients and look | Merck's formula | May differ | | Typical price | Usually higher | Usually lower |

Our ivermectin price page shows what the Iverheal tablets we sell cost by pack size.

Why is there no 6mg or 12mg ivermectin tablet in the US?

The FDA-approved oral ivermectin products in the US are 3mg tablets. No company sells an approved 6mg or 12mg tablet here. Tablets in those strengths that you see online, including Iverheal 6, 12 and 24, are made for markets outside the US, which is a different matter (see below).

When a prescriber wants a different strength, a licensed pharmacy can compound it: a pharmacist prepares capsules for a specific patient against a prescription. Compounded medicines aren't FDA-approved products. They're made under pharmacy rules set by federal law and state boards. Our guide to 3mg vs 6mg vs 12mg goes into how the strengths differ.

What about imported tablets and veterinary products?

You'll find ivermectin tablets online that were made for markets outside the US. Iverheal, the brand we sell, is one of them: Iverheal 3, Iverheal 6, Iverheal 12 and Iverheal 24 are made in India by Healing Pharma. Tablets like these contain ivermectin as the active ingredient, but they aren't FDA-approved products, the FDA hasn't reviewed how they were made, and their labels follow other countries' rules. Unlicensed overseas sellers can also ship products that don't match their label at all. That's why we name the maker and strength on every product page, supply Iverheal only against a valid prescription from a licensed US prescriber, and have a pharmacist review every order.

Veterinary ivermectin is a different category again. Pastes, pour-ons, injectables and livestock drenches are made and labeled for animals. They can be far more concentrated than human tablets and may contain inactive ingredients that haven't been tested in people. The FDA has warned people not to take animal products. We cover the reasons in more detail in why you shouldn't use veterinary ivermectin.

If you specifically want an FDA-approved product, that means Stromectol or an approved generic from a US pharmacy, with a prescription or under your state's pharmacist-dispensing law where one applies. Our state guide shows which states have such a law.

Does it matter which maker you get?

For most people, no. An approved generic and the brand contain the same medicine at the same strength, and the FDA holds both to its quality rules. Pharmacies usually stock one generic at a time and may switch suppliers, so the carton you get next time can look different from the last one. That's normal.

It's worth asking about the maker if you've reacted to an inactive ingredient before, or if your prescriber has written "brand medically necessary" or "dispense as written" on the prescription. In that case the pharmacy should fill it with the brand. If you're working out which route fits you, prescription or a state's pharmacist-dispensing law, our guide on how to get ivermectin walks through both.

How can you check who made your tablets?

You can confirm the source of any ivermectin product yourself:

1. Read the carton and the pharmacy label. Look for the company name, "USP" and the NDC, a 10- or 11-digit National Drug Code that identifies the labeler, product and package.
2. Look it up on DailyMed. DailyMed, run by the National Library of Medicine, holds the official labeling for US medicines. Search "ivermectin" or the NDC to see the labeler and the full prescribing information.
3. Check the FDA's Orange Book. It lists approved drug products and which generics the FDA rates as equivalent to the brand.
4. Ask your pharmacist. They can tell you exactly which product they dispense, and whether it's brand or generic.

If you order from us, you get the Iverheal strength you choose, made by Healing Pharma in India; the product pages show each carton. Our contact page reaches the team if you have questions before ordering.

Sources

• FDA: Generic Drug Facts
• FDA: Human Drug Compounding
• MedlinePlus: Ivermectin, US National Library of Medicine