Prescription drug · ANDA
Fluconazole NDC 0904-6500
Fluconazole 100 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6500-06 | 00904650006 | 50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 25, 2015 | |
| 0904-6500-61 | 00904650061 | 100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 25, 2015 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076658
- 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 0904-6500_3c6a1b79-df4e-4281-959e-8f41c97b13c0SPL ID 3c6a1b79-df4e-4281-959e-8f41c97b13c0SPL set ID 13184b13-e252-4b4d-a3e2-cfc4ad3d55b7RxCUI 197698, 197700UNII 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 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
N400904650006followed by a unit qualifier and the quantityPackage 00904-6500-06. 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 tablets are 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 tablets were 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 tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076658
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 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1448 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3400 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-146 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | direct rx | 72189-143 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Sportpharm LLC | 85766-104 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Sportpharm LLC | 85766-101 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Sportpharm LLC | 85766-102 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Sportpharm LLC | 85766-103 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6501 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-145 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-143 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-144 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7875 |