CICLOPIROX OLAMINE is a Topical Suspension in the Human Prescription Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Ciclopirox Olamine.
| Product ID | 69315-309_232bf664-5638-47a3-a464-440467039140 |
| NDC | 69315-309 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CICLOPIROX OLAMINE |
| Generic Name | Ciclopirox Olamine |
| Dosage Form | Suspension |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA019824 |
| Labeler Name | Leading Pharma, LLC |
| Substance Name | CICLOPIROX OLAMINE |
| Active Ingredient Strength | 8 mg/mL |
| Pharm Classes | Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-02-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019824 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-02-25 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019824 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-02-25 |
| Ingredient | Strength |
|---|---|
| CICLOPIROX OLAMINE | 7.7 mg/mL |
| SPL SET ID: | 370ab878-2753-435f-ae06-67ec9f9502e1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0168-0313 | ciclopirox olamine | ciclopirox olamine |
| 0713-0638 | Ciclopirox Olamine | Ciclopirox Olamine |
| 45802-138 | Ciclopirox Olamine | Ciclopirox Olamine |
| 45802-400 | Ciclopirox Olamine | Ciclopirox Olamine |
| 49999-646 | CICLOPIROX OLAMINE | CICLOPIROX OLAMINE |
| 51672-1318 | Ciclopirox Olamine | ciclopirox olamine |
| 53002-9450 | Ciclopirox Olamine | ciclopirox olamine |
| 63629-2522 | Ciclopirox Olamine | Ciclopirox Olamine |
| 63629-8624 | Ciclopirox Olamine | Ciclopirox Olamine |
| 63629-8625 | Ciclopirox Olamine | Ciclopirox Olamine |
| 63629-8626 | Ciclopirox Olamine | Ciclopirox Olamine |
| 63629-8627 | Ciclopirox Olamine | Ciclopirox Olamine |
| 68071-1608 | Ciclopirox Olamine | Ciclopirox Olamine |
| 68071-4162 | Ciclopirox Olamine | ciclopirox olamine |
| 68258-3996 | Ciclopirox Olamine | Ciclopirox Olamine |
| 68462-297 | Ciclopirox Olamine | Ciclopirox Olamine |
| 69315-309 | CICLOPIROX OLAMINE | CICLOPIROX OLAMINE |
| 80425-0225 | Ciclopirox Olamine | Ciclopirox Olamine |
| 43538-540 | Loprox | ciclopirox olamine |
| 43538-541 | Loprox | Ciclopirox Olamine |
| 43538-550 | Loprox | ciclopirox olamine |
| 43538-551 | Loprox | Ciclopirox Olamine |