Prescription drug · ANDA
Ciclopirox Olamine NDC 71335-2915
Ciclopirox olamine 7.7 mg/100mL · Suspension · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2915-1 | 71335291501 | 1 BOTTLE in 1 CARTON (71335-2915-1) / 30 mL in 1 BOTTLEMarketed 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)
- Ciclopirox Olamine
- Generic name (nonproprietary)
- ciclopirox olamine
- Active ingredients
- Ciclopirox olamine — 7.7 mg/100mL
- Dosage form
- Suspension
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077676
- 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 71335-2915_60371a57-545f-458b-8ca1-016eb9b78629SPL ID 60371a57-545f-458b-8ca1-016eb9b78629SPL set ID 835a6370-f331-4b15-b6fa-beafe027f187RxCUI 309290UNII 50MD4SB4AP
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
N471335291501followed by a unit qualifier and the quantityPackage 71335-2915-01. 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 Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077676
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 Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 71335-2717 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 63629-8627 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 72162-1406 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/mL | SuspensionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-400 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 63629-2522 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.