Prescription drug · ANDA
Fluconazole NDC 63629-8970
Fluconazole 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8970-1 | 63629897001 | 30 TABLET in 1 BOTTLE (63629-8970-1)Marketed from Oct 8, 2024 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078423
- 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 63629-8970_f0a93e29-d92a-4f5c-835c-5cfd2e134f8dSPL ID f0a93e29-d92a-4f5c-835c-5cfd2e134f8dSPL set ID b94ca865-ab2f-466c-9913-dde9376e4533RxCUI 197701UNII 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
N463629897001followed by a unit qualifier and the quantityPackage 63629-8970-01. 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 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 to amphotericin B in non-HIV infected patients have n…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078423
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 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1776 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6733 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Proficient Rx LP | 71205-650 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9091 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3901 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9134 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1895 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-425 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-424 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-426 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-427 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1948 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-990 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-991 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-992 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-993 |