Prescription drug · ANDA
ciclopirox NDC 71335-2757
Ciclopirox 7.7 mg/g · Gel · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2757-1 | 71335275701 | 30 g in 1 TUBE (71335-2757-1)Marketed from Aug 8, 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)
- ciclopirox
- Generic name (nonproprietary)
- ciclopirox
- Active ingredients
- Ciclopirox — 7.7 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091595
- Marketing start
- Listing expires
- Other FDA classes
- Decreased DNA Replication (Physiologic effect)Decreased Protein Synthesis (Physiologic effect)Decreased RNA Replication (Physiologic effect)Protein Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2757_f12c1396-d3e6-46a4-b8b3-2cf17dc17f06SPL ID f12c1396-d3e6-46a4-b8b3-2cf17dc17f06SPL set ID 810bfb01-a69d-4b00-ac2d-b92e7ddad9f9RxCUI 313941UNII 19W019ZDRJ
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
N471335275701followed by a unit qualifier and the quantityPackage 71335-2757-01. 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 Superficial Dermatophyte Infections Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum . Seborrheic Dermatitis Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091595
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 |
|---|---|---|---|---|
| ciclopirox | Ciclopirox 7.7 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-455 |