Prescription drug · ANDA
fluconazole NDC 70518-2415
Fluconazole 100 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2415-0 | 70518241500 | 30 TABLET in 1 BLISTER PACK (70518-2415-0)Marketed from Nov 11, 2019 | |
| 70518-2415-1 | 70518241501 | 16 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1)Marketed from Aug 23, 2024 | |
| 70518-2415-2 | 70518241502 | 8 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2)Marketed from Aug 23, 2024 | |
| 70518-2415-5 | 70518241505 | 30 TABLET in 1 BLISTER PACK (70518-2415-5)Marketed from Sep 15, 2026 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208963
- 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 70518-2415_5c03f57b-cecb-2959-e063-6294a90a61cbSPL ID 5c03f57b-cecb-2959-e063-6294a90a61cb
- 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
N470518241500followed by a unit qualifier and the quantityPackage 70518-2415-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 208963
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 | A-S Medication Solutions | 50090-5299 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1065 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-4425 |
| fluconazole | Fluconazole 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1063 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1064 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1066 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4501 |
| fluconazole | Fluconazole 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1137 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1140 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1138 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1139 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | direct rx | 72189-140 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | direct rx | 72189-149 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Proficient Rx LP | 71205-081 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Direct Rx | 61919-493 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-4864 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0686 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0769 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4163 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Proficient Rx LP | 71205-283 |