Prescription drug · ANDA
Fluconazole NDC 0409-3435
Fluconazole 200 mg/100mL · Injection, Solution · Intravenous · Hospira, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-3435-24 | 00409343524 | 24 POUCH in 1 CARTON (0409-3435-24) / 1 BAG in 1 POUCH (0409-3435-01) / 100 mL in 1 BAGMarketed from Jan 6, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079104
- 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 0409-3435_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5SPL ID f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5SPL set ID 22ebc3fb-ee81-44bd-a6e3-5e759ee724a8RxCUI 1721314, 1721315UNII 8VZV102JFY
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400409343524followed by a unit qualifier and the quantityPackage 00409-3435-24. 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 in Sodium Chloride Injection, USP is indicated for the treatment of: 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. 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. Prophylaxis: Fluconazole is also indicated to …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079104
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 |
|---|---|---|---|---|
| Fluconazole | Fluconazole 2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-184 |
| Fluconazole | Fluconazole 2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-184 |
| Fluconazole | Fluconazole 400 mg/200mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4321 |