Prescription drug · ANDA
Fluconazole NDC 63187-878
Fluconazole 200 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-878-01 | 63187087801 | 1 TABLET in 1 BOTTLE (63187-878-01)Marketed from Aug 1, 2017 | |
| 63187-878-02 | 63187087802 | 2 TABLET in 1 BOTTLE (63187-878-02)Marketed from Aug 1, 2017 | |
| 63187-878-30 | 63187087830 | 30 TABLET in 1 BOTTLE (63187-878-30)Marketed from Aug 1, 2017 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077253
- 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 63187-878_05e11a44-c072-4969-9175-1caa92458ad7SPL ID 05e11a44-c072-4969-9175-1caa92458ad7SPL set ID fbb1bda3-f733-4404-9c9d-46c418700c03RxCUI 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
N463187087801followed by a unit qualifier and the quantityPackage 63187-0878-01. 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 USP are indicated for the treatment of: • Vaginal candidiasis (vaginal yeast infections due to Candida ). • 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 tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077253
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 100 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-397 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-396 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-398 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-399 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-119 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Coupler LLC | 67046-1546 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-033 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-803 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Proficient Rx LP | 82804-218 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4332 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-252 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-251 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | BluePoint Laboratories | 68001-253 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-254 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-104 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-101 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-102 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-824 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2268 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2557 |
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