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NDC 63629-8627-01 Ciclopirox Olamine 7.7 mg/100mL Details
Ciclopirox Olamine 7.7 mg/100mL
Ciclopirox Olamine is a TOPICAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CICLOPIROX OLAMINE.
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: 63629-8627-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ciclopirox Topical
Product Information
| NDC | 63629-8627 |
|---|---|
| Product ID | 63629-8627_00b5dd85-24e0-1c81-e063-6394a90a24d3 |
| Associated GPIs | |
| GCN Sequence Number | 040298 |
| GCN Sequence Number Description | ciclopirox olamine SUSPENSION 0.77 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 95353 |
| HICL Sequence Number | 003203 |
| HICL Sequence Number Description | CICLOPIROX OLAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Ciclopirox Olamine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ciclopirox Olamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | TOPICAL |
| Active Ingredient Strength | 7.7 |
| Active Ingredient Units | mg/100mL |
| Substance Name | CICLOPIROX OLAMINE |
| Labeler Name | Bryant Ranch Prepack |
| 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 | ANDA077676 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8627-01 (63629862701)
| NDC Package Code | 63629-8627-1 |
|---|---|
| Billing NDC | 63629862701 |
| Package | 1 BOTTLE in 1 CARTON (63629-8627-1) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2006-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |