Prescription drug · NDA AUTHORIZED GENERIC
Fluconazole NDC 59762-5030
Fluconazole 40 mg/mL · Powder, For suspension · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-5030-1 | 59762503001 | 1 BOTTLE in 1 CARTON (59762-5030-1) / 35 mL in 1 BOTTLEMarketed from Dec 23, 1993 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fluconazole
- Generic name (nonproprietary)
- fluconazole
- Active ingredients
- Fluconazole — 40 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020090
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 59762-5030_5a926244-1653-4a4e-9a60-9713a91d2485SPL ID 5a926244-1653-4a4e-9a60-9713a91d2485SPL set ID 737e0fac-a2d2-4053-a0d7-edbfb6248f69RxCUI 197698, 197699, 197700, 197701, 310352, 310353UNII 8VZV102JFYUPC 0359762503015, 0359762501516, 0359762502919
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459762503001followed by a unit qualifier and the quantityPackage 59762-5030-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Fluconazole is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. Specime…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diflucanfluconazole | Fluconazole 1400 mg/35mL | Powder, For suspensionOral | Roerig | 0049-3450 |
| Fluconazole | Fluconazole 10 mg/mL | Powder, For suspensionOral | Mylan Pharmaceuticals Inc. | 59762-5029 |