Prescription drug · ANDA
Ketoconazole NDC 71335-2839
Ketoconazole 20 mg/mL · Shampoo, Suspension · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2839-1 | 7133528390171335283901 | 120 mL in 1 BOTTLE (71335-2839-1)Marketed from Oct 24, 2025 |
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/mL
- Dosage form
- Shampoo, Suspension
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076419
- 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 71335-2839_b6f5f195-1e32-4e50-9414-2d48c13eae5fSPL ID b6f5f195-1e32-4e50-9414-2d48c13eae5fSPL set ID 6d394f8c-d49e-45ff-b7a9-a14aba9bb9cfRxCUI 106336UNII 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
N471335283901followed by a unit qualifier and the quantityPackage 71335-2839-01. 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 Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur b…
Excerpt only. Read the full label for complete information.
About NDC 71335-2839
- What is NDC 71335-2839?
- 71335-2839 is the product NDC for Ketoconazole, Ketoconazole 20 mg/mL shampoo, suspension, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 076419
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/mL | Shampoo, SuspensionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-465 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Bryant Ranch Prepack | 63629-8675 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | NuCare Pharmaceuticals,Inc. | 68071-3930 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | NuCare Pharmaceuticals, Inc. | 68071-5294 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Bryant Ranch Prepack | 72162-1409 |
| Ketoconazole | Ketoconazole 20 mg/mL | Shampoo, SuspensionTopical | Northstar Rx LLC | 72603-878 |