Quick answers
- What is Claravis?
- Claravis is a brand name of Isotretinoin, a prescription medicine. The FDA NDC Directory lists 4 Claravis products in 4 strengths and forms.
- Who makes Claravis?
- Teva Pharms USA holds the FDA application for Claravis (ANDA076135, approved April 11, 2003).
- Is there a generic or store brand of Claravis?
- Yes. The FDA NDC Directory lists 20 other products with the same active ingredients, strength and form as a Claravis product, 20 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Claravis?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Claravis strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Claravis been recalled?
- FDA enforcement reports list 1 recall of Claravis products; the newest started April 6, 2026. A recall usually concerns specific lots, not every product.
What Claravis is
Each Claravis product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Isotretinoin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| isotretinoin 10 mg capsule, liquid filled (oral) | Claravis | 5 products, 3 companies | DailyMed |
| isotretinoin 20 mg capsule, liquid filled (oral) | Claravis | 5 products, 3 companies | DailyMed |
| isotretinoin 30 mg capsule, liquid filled (oral) | Claravis | 5 products, 3 companies | DailyMed |
| isotretinoin 40 mg capsule, liquid filled (oral) | Claravis | 5 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Isotretinoin →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA076135 | Teva Pharms USA | April 11, 2003 | 3 |
| ANDA076356 | Teva Pharms USA | April 11, 2003 | 1 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| isotretinoin 10 mg capsule, liquid filled | Generic: Claravis | $1.96 per capsule Generic of the same strength and form: $1.96–$4.21 per capsule |
| isotretinoin 20 mg capsule, liquid filled | Generic: Claravis | $1.93 per capsule Generic of the same strength and form: $1.93–$4.18 per capsule |
| isotretinoin 30 mg capsule, liquid filled | Generic: Claravis | $2.01 per capsule Generic of the same strength and form: $2.01–$5.43 per capsule |
| isotretinoin 40 mg capsule, liquid filled | Generic: Claravis | $2.19 per capsule Generic of the same strength and form: $2.19–$5.83 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Claravis
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Claravis products.
- Teva Pharmaceuticals USA, Inc.4 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 6, 2026 · Class II · Ongoing · D-0521-2026
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx — Teva Pharmaceuticals USA, Inc
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.