Ciclopirox is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Ciclopirox.
| Product ID | 0168-0407_0c2acee6-0de3-4a80-9483-c45c8506e504 |
| NDC | 0168-0407 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ciclopirox |
| Generic Name | Ciclopirox |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2008-06-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077896 |
| Labeler Name | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Substance Name | CICLOPIROX |
| Active Ingredient Strength | 8 mg/g |
| Pharm Classes | Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2008-06-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077896 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2008-06-10 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA077896 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2008-06-10 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA077896 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2012-07-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA077896 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2008-06-10 |
| Marketing End Date | 2012-07-17 |
| Ingredient | Strength |
|---|---|
| CICLOPIROX | 7.7 mg/g |
| SPL SET ID: | 88324009-d5cc-4982-be3e-058e0436f608 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0168-0314 | Ciclopirox | ciclopirox |
| 0168-0407 | Ciclopirox | Ciclopirox |
| 0168-0449 | Ciclopirox | Ciclopirox |
| 0168-0522 | Ciclopirox | ciclopirox |
| 0574-2061 | CICLOPIROX | CICLOPIROX |
| 0591-2159 | Ciclopirox | Ciclopirox |
| 0713-0317 | Ciclopirox | CICLOPIROX |
| 21695-475 | Ciclopirox | Ciclopirox |
| 42192-714 | Ciclopirox | Ciclopirox |
| 42192-715 | Ciclopirox | Ciclopirox |
| 45802-141 | Ciclopirox | Ciclopirox |
| 45802-401 | Ciclopirox | Ciclopirox |
| 47781-530 | Ciclopirox | Ciclopirox |
| 50383-419 | Ciclopirox | Ciclopirox |
| 51672-1323 | Ciclopirox | Ciclopirox |
| 51672-1351 | Ciclopirox | ciclopirox |
| 51672-5302 | Ciclopirox | ciclopirox |
| 52565-032 | Ciclopirox | ciclopirox |
| 61360-1351 | Ciclopirox | ciclopirox |
| 61748-200 | CICLOPIROX | CICLOPIROX |
| 63629-8620 | CICLOPIROX | CICLOPIROX |
| 68071-1524 | Ciclopirox | Ciclopirox |
| 68071-4412 | Ciclopirox | Ciclopirox |
| 68462-455 | ciclopirox | ciclopirox |
| 68788-6797 | Ciclopirox | Ciclopirox |
| 68788-7138 | Ciclopirox | Ciclopirox |
| 68071-4977 | Ciclopirox | Ciclopirox |
| 43538-500 | Ciclodan | ciclopirox |
| 43538-501 | Ciclodan | ciclopirox |
| 0187-5180 | Penlac | ciclopirox |