PillIsotretinoin
Brands: Claravis · Isotretinoin
4 active makers
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US acquisition costNADAC · per unit
Average across 27 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it4 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Upsher-Smith Laboratories, LLC | unknown | 8 | SUPPLYING |
| Mayne Pharma Inc. | unknown | 8 | SUPPLYING |
| Teva Pharmaceuticals USA, Inc. | unknown | 7 | SUPPLYING |
| Amneal Pharmaceuticals LLC | unknown | 4 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Apr 6, 2026RECALLRecall (Class II): Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister pack…
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin — Recalling firm: Teva Pharmaceuticals USA, Inc — Nationwide in the USA, Puerto Rico and Virgin Islands
- Oct 16, 2019RECALLRecall (Class III): Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distribute…
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. — Recalling firm: Amneal Pharmaceuticals, Inc. — Recalled product was distributed to retailers and wholesalers who may have further distribute the product.