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NDC 63646-0010-04 Ketoconazole 20 mg/mL Details
Ketoconazole 20 mg/mL
Ketoconazole is a TOPICAL SHAMPOO, SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TOLMAR Inc.. The primary component is KETOCONAZOLE.
MedlinePlus Drug Summary
Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used to control flaking, scaling, and itching of the scalp caused by dandruff. Ketoconazole is in a class of antifungal medications called imidazoles. It works by slowing the growth of fungi that cause infection.
Related Packages: 63646-0010-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketoconazole Topical
Product Information
| NDC | 63646-0010 |
|---|---|
| Product ID | 63646-010_eea5b1d8-7b6e-4783-afb5-3049efb9e5b1 |
| Associated GPIs | 90154045004510 |
| GCN Sequence Number | 015568 |
| GCN Sequence Number Description | ketoconazole SHAMPOO 2 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 31271 |
| 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 | SHAMPOO, SUSPENSION |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOCONAZOLE |
| Labeler Name | TOLMAR Inc. |
| 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 | ANDA076942 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63646-0010-04 (63646001004)
| NDC Package Code | 63646-010-04 |
|---|---|
| Billing NDC | 63646001004 |
| Package | 120 mL in 1 BOTTLE, PLASTIC (63646-010-04) |
| Marketing Start Date | 2005-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.09813 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | KETOCONAZOLE 2% SHAMPOO |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |