Prescription drug · ANDA
Fluconazole NDC 67046-2044
Fluconazole 200 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-2044-3 | 6704620440367046204403 | 30 TABLET in 1 BLISTER PACK (67046-2044-3)Marketed from Oct 26, 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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-2044_5ec0ddfa-b69f-41a2-e063-6294a90ae449SPL ID 5ec0ddfa-b69f-41a2-e063-6294a90ae449
- 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
N467046204403followed by a unit qualifier and the quantityPackage 67046-2044-03. 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.
About NDC 67046-2044
- What is NDC 67046-2044?
- 67046-2044 is the product NDC for Fluconazole, Fluconazole 200 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluconazole.
- What is the active ingredient?
- Fluconazole.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluconazole?
- 162 other product NDCs are listed under this name. See all Fluconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-0623 | 67046-0623-03 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4723 | 70518-4723-00 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4163 | 68788-4163-0068788-4163-0168788-4163-02+4 more |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-2000 | 67046-2000-03 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-396 | 77771-0396-30 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-397 | 77771-0397-0177771-0397-30 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-398 | 77771-0398-1177771-0398-13 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-399 | 77771-0399-0177771-0399-30 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4413 | 70518-4413-00 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4336 | 70518-4336-00 |
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 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-5764 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-889 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-824 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-803 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Proficient Rx LP | 63187-878 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Coupler LLC | 67046-1546 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-2000 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-251 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-252 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | BluePoint Laboratories | 68001-253 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-254 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2557 |
| 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 | Glenmark Pharmaceuticals Inc., USA | 68462-104 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-119 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4332 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4413 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Proficient Rx LP | 71205-796 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2268 |
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