Prescription drug · ANDA
Ciclopirox NDC 72162-1126
Ciclopirox 7.7 mg/g · Gel · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1126-1 | 72162112601 | 1 TUBE in 1 CARTON (72162-1126-1) / 100 g in 1 TUBEMarketed from Mar 11, 2024 | |
| 72162-1126-2 | 72162112602 | 1 TUBE in 1 CARTON (72162-1126-2) / 45 g in 1 TUBEMarketed from Mar 11, 2024 | |
| 72162-1126-3 | 72162112603 | 1 TUBE in 1 CARTON (72162-1126-3) / 30 g in 1 TUBEMarketed from Mar 11, 2024 |
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 078266
- 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 72162-1126_fdda6ce3-b610-4510-95fc-0df24f9e5903SPL ID fdda6ce3-b610-4510-95fc-0df24f9e5903SPL set ID 51993bbb-f145-4662-8138-4db774cc0513RxCUI 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
N472162112601followed by a unit qualifier and the quantityPackage 72162-1126-01. 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, 0.77% 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, 0.77% 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 078266
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 | Padagis US LLC | 0574-2061 |
| Ciclopirox | Ciclopirox 7.7 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8622 |
| Ciclopirox | Ciclopirox 7.7 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8620 |
| Ciclopirox | Ciclopirox 7.7 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8621 |