Prescription drug · ANDA
Fluconazole NDC 72673-091
Fluconazole 40 mg/mL · Powder, For suspension · Oral · Zhejiang Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72673-091-14 | 72673009114 | 1 BOTTLE in 1 CARTON (72673-091-14) / 35 mL in 1 BOTTLEMarketed from Apr 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 40 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215738
- 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 72673-091_47d8769c-b294-65ab-e063-6394a90a8bffSPL ID 47d8769c-b294-65ab-e063-6394a90a8bffSPL set ID 2a3ba181-5baa-5942-e063-6294a90a82b2RxCUI 310353UNII 8VZV102JFYUPC 0372673091143
- 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
N472673009114followed by a unit qualifier and the quantityPackage 72673-0091-14. 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 for oral suspension is indicated for the treatment of: 1. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 2. Cryptococcal meningitis . Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been con…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215738
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 40 mg/mL | Powder, For suspensionOral | Slate Run Pharmaceuticals | 70436-227 |