Over-the-counter drug · NDA
Nizoral (Ketoconazole) NDC 55505-196
Ketoconazole 10 mg/mL · Shampoo · Topical · Kramer Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55505-196-33 | 5550501963355505019633 | 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLEMarketed from Jun 16, 2022 | |
| 55505-196-40 | 5550501964055505019640 | 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLEMarketed from Jun 16, 2022 | |
| 55505-196-47 | 5550501964755505019647 | 4 mL in 1 PACKET (55505-196-47)Marketed from Mar 1, 2024 | |
| 55505-196-57 | 5550501965755505019657 | 2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLEMarketed from Apr 29, 2023 | |
| 55505-196-65 | 5550501966555505019665 | 1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTONMarketed from Jun 16, 2022 | |
| 55505-196-68 | 5550501966855505019668 | 3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLEMarketed from Oct 15, 2022 | |
| 55505-196-72 | 5550501967255505019672 | 2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLEMarketed from Dec 1, 2023 | |
| 55505-196-84 | 5550501968455505019684 | 2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLEMarketed from Jun 1, 2025 | |
| 55505-196-85 | 5550501968555505019685 | 1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLEMarketed from Jan 12, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nizoral
- Generic name (nonproprietary)
- ketoconazole
- Active ingredients
- Ketoconazole — 10 mg/mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- Kramer LaboratoriesNDC labeler code 55505
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020310
- 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 55505-196_78acf0f9-ecab-41b3-9319-d67e7ab12a55SPL ID 78acf0f9-ecab-41b3-9319-d67e7ab12a55
- 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
N455505019633followed by a unit qualifier and the quantityPackage 55505-0196-33. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 55505-196
- What is NDC 55505-196?
- 55505-196 is the product NDC for Nizoral (ketoconazole), Ketoconazole 10 mg/mL shampoo, listed with the FDA by Kramer Laboratories. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nizoral (Ketoconazole).
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- Kramer Laboratories, NDC labeler code 55505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nizoral?
- 2 other product NDCs are listed under this name. See all Nizoral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nizoral products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nizoralketoconazole | Ketoconazole 1 g/100mL | ShampooTopical | Kramer Laboratories | 55505-232 | 55505-0232-65 |
| Nizoralketoconazole | Ketoconazole 10 mg/mL | ShampooTopical | Kramer Laboratories | 55505-233 | 55505-0233-65 |
Other NDCs under NDA 020310
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 |
|---|---|---|---|---|
| Nizoralketoconazole | Ketoconazole 1 g/100mL | ShampooTopical | Kramer Laboratories | 55505-232 |
| Nizoralketoconazole | Ketoconazole 10 mg/mL | ShampooTopical | Kramer Laboratories | 55505-233 |