Prescription drug · ANDA
Ketoconazole NDC 50090-6069
Ketoconazole 20 mg/g · Cream · Topical · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6069-0 | 50090606900 | 1 TUBE in 1 CARTON (50090-6069-0) / 15 g in 1 TUBEMarketed from Sep 12, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ketoconazole
- Generic name (nonproprietary)
- ketoconazole
- Active ingredients
- Ketoconazole — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075638
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6069_9fe63a1b-7944-4b27-bd49-288fcb59eccdSPL ID 9fe63a1b-7944-4b27-bd49-288fcb59eccdSPL set ID 8ef1117d-0b63-4c26-beaa-7667b2387e14RxCUI 203088UNII R9400W927I
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090606900followed by a unit qualifier and the quantityPackage 50090-6069-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075638
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-1709 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1298 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Golden State Medical Supply, Inc. | 51407-279 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Proficient Rx LP | 63187-774 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | NORTHSTAR RX LLC | 16714-955 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | IPG PHARMACEUTICALS, INC. | 71085-008 |