Prescription drug · ANDA
Ketoconazole NDC 16714-955
Ketoconazole 20 mg/g · Cream · Topical · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-955-01 | 1671409550116714095501 | 1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBEMarketed from Apr 25, 2019 | |
| 16714-955-02 | 1671409550216714095502 | 1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBEMarketed from Apr 25, 2019 | |
| 16714-955-03 | 1671409550316714095503 | 1 TUBE in 1 CARTON (16714-955-03) / 60 g in 1 TUBEMarketed from Apr 25, 2019 |
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)
- Ketoconazole
- Generic name (nonproprietary)
- ketoconazole
- Active ingredients
- Ketoconazole — 20 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- NORTHSTAR RX LLCNDC labeler code 16714
- 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 16714-955_494f72d9-37d0-5066-e063-6394a90a95bcSPL ID 494f72d9-37d0-5066-e063-6394a90a95bcSPL set ID bf3e48fd-e063-42e6-acd1-580ddc6e93beRxCUI 203088UNII R9400W927IUPC 0316714955025
- 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
N416714095501followed by a unit qualifier and the quantityPackage 16714-0955-01. 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.
About NDC 16714-955
- What is NDC 16714-955?
- 16714-955 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by NORTHSTAR RX LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketoconazole.
- What is the active ingredient?
- Ketoconazole.
- Who is the labeler?
- NORTHSTAR RX LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketoconazole?
- 54 other product NDCs are listed under this name. See all Ketoconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketoconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | IPG PHARMACEUTICALS, INC. | 71085-008 | 71085-0008-45 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amerisyn LLC | 87564-051 | 87564-0051-1087564-0051-30 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | NuCare Pharmaceuticals, Inc. | 68071-5294 | 68071-5294-04 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Northstar Rx LLC | 72603-878 | 72603-0878-01 |
| Ketoconazole | Ketoconazole 200 mg/1 | TabletOral | Amici Pharma Inc. | 69292-224 | 69292-0224-01 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Preferred Pharmaceuticals Inc. | 68788-8868 | 68788-8868-01 |
| Ketoconazole | Ketoconazole 20 mg/mL | ShampooTopical | Zydus Lifesciences Limited | 70771-1874 | 70771-1874-07 |
| Ketoconazole | Ketoconazole 20 mg/mL | ShampooTopical | Viona Pharmaceuticals Inc | 72578-156 | 72578-0156-12 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Cosette Pharmaceuticals, Inc. | 0713-0592 | 00713-0592-04 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | A-S Medication Solutions | 50090-7538 | 50090-7538-00 |
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 | A-S Medication Solutions | 50090-6069 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Golden State Medical Supply, Inc. | 51407-279 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1298 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | Proficient Rx LP | 63187-774 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-1709 |
| Ketoconazole | Ketoconazole 20 mg/g | CreamTopical | IPG PHARMACEUTICALS, INC. | 71085-008 |