The short version
6 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
1% ketoconazole
Ketoconazole · KETOCONAZOLE 10 mg/mL · Shampoo · Topical · Tagrid Llc
NDC 85384-0001-01 · 250 mL in 1 BOTTLE · OTC MONOGRAPH DRUG · View full market →
Medicare Part D
Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for ketoconazole (other) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Regulatory
- Application
- M005
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Ketoconazole (Shampoo)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Guangzhou ChuanMa International Trading Co.,Ltd. | KETOCONAZOLE 1 g/100mL | Jul 15, 2026 | Sep 3, 2026 |
| Kramer Laboratories | KETOCONAZOLE 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| ANI Pharmaceuticals, Inc. | KETOCONAZOLE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Kramer Laboratories | KETOCONAZOLE 1 g/100mL | Jul 15, 2026 | Sep 2, 2026 |
| Tagrid Llc | KETOCONAZOLE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Viona Pharmaceuticals Inc | KETOCONAZOLE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | KETOCONAZOLE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Guangzhou ChuanMa International Trading Co.,Ltd. | KETOCONAZOLE N-OXIDE 1 g/100mL | Jul 15, 2026 | Aug 19, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "1% ketoconazole — NDC 85384-0001-01," retrieved September 3, 2026, https://drugdashboards.com/drug/85384000101.
Free to cite with attribution — see how the data is put together.