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NDC 45802-0141-67 Ciclopirox 80 mg/mL Details
Ciclopirox 80 mg/mL
Ciclopirox is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is CICLOPIROX.
MedlinePlus Drug Summary
Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
Related Packages: 45802-0141-67Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ciclopirox Topical
Product Information
| NDC | 45802-0141 |
|---|---|
| Product ID | 45802-141_35caab7d-7077-4610-937a-8b593875d0b7 |
| Associated GPIs | 90150030002020 |
| GCN Sequence Number | 037020 |
| GCN Sequence Number Description | ciclopirox SOLUTION 8 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 08040 |
| HICL Sequence Number | 016915 |
| HICL Sequence Number Description | CICLOPIROX |
| Brand/Generic | Generic |
| Proprietary Name | Ciclopirox |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ciclopirox |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/mL |
| Substance Name | CICLOPIROX |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077623 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0141-67 (45802014167)
| NDC Package Code | 45802-141-67 |
|---|---|
| Billing NDC | 45802014167 |
| Package | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-141-67) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2007-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.95243 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | CICLOPIROX 8% SOLUTION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis