Search by Drug Name or NDC
NDC 35573-0433-02 KETOCONAZOLE 200 mg/1 Details
KETOCONAZOLE 200 mg/1
KETOCONAZOLE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals, LLC. The primary component is KETOCONAZOLE.
MedlinePlus Drug Summary
Ketoconazole is used to treat fungal infections when other medications are not available or cannot be tolerated. Ketoconazole should not be used to treat fungal meningitis (infection of the membranes surrounding the brain and spinal cord caused by a fungus) or fungal nail infections. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.
Related Packages: 35573-0433-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketoconazole
Product Information
| NDC | 35573-0433 |
|---|---|
| Product ID | 35573-433_748e48d8-09d3-413c-b724-883b6b47f01e |
| Associated GPIs | 11404040000310 |
| GCN Sequence Number | 009544 |
| GCN Sequence Number Description | ketoconazole TABLET 200 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 42590 |
| HICL Sequence Number | 004132 |
| HICL Sequence Number Description | KETOCONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | KETOCONAZOLE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ketoconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | KETOCONAZOLE |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075912 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 35573-0433-02 (35573043302)
| NDC Package Code | 35573-433-02 |
|---|---|
| Billing NDC | 35573043302 |
| Package | 100 TABLET in 1 BOTTLE (35573-433-02) |
| Marketing Start Date | 2020-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.77282 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | KETOCONAZOLE 200 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| 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