NDC 67046-1546-03 - Fluconazole
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 67046-1546
- Requested NDC
- 67046-1546-03
- Package NDCs from labels
- 67046-1546-3, 67046-1546-03
- Manufacturer
- Coupler LLC | Glenmark Pharmaceuticals Inc
- Effective date
- 2025-04-09
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Fluconazole - Coupler LLC | Glenmark Pharmaceuticals Inc | Coupler LLC | Glenmark Pharmaceuticals Inc | 2025-04-09 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-1546-3 | Fluconazole | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67046-1546 | FLUCONAZOLE TABLET [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250410_325d5d69-5132-79ea-e063-6294a90afdd0.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | aaf9e5f8-048e-407c-bc11-ad4edff85c05 | 2026-09-10 | Warnings, Adverse reactions | ANDA077253 197698 8VZV102JFY |
| Leader Artificial Tears 15 mL | POLYVINYL ALCOHOL, POVIDONE | Cardinal Health | 8cccc589-3a8e-baad-e053-2a95a90ab8c7 | 2026-09-09 | Warnings | FZ989GH94E |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 1c82929f-934b-4df4-b24f-1e5da090fd8a | 2026-09-04 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS | POVIDONE, POLYVINYL ALCOHOL SOLUTION | Harrow Eye, LLC | 049e9cc9-0663-53bc-e063-6294a90a2c4f | 2026-09-04 | Warnings | FZ989GH94E |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2bd1c038-ab82-496c-8129-3182238ad1a1 | 2026-09-01 | Warnings, Adverse reactions | 197698 8VZV102JFY |
| Rohto Optic Glow | NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff | 2026-08-20 | Warnings | FZ989GH94E |
| fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 16b6fba0-b96f-4252-a70d-31dc61400298 | 2026-08-20 | Warnings, Adverse reactions | 197700 8VZV102JFY |
| Rohto Preservative Free Dry Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | f4b1974c-2412-45f6-b79d-88b8a0bcb608 | 2026-08-18 | Warnings | FZ989GH94E |
| Rohto Dry-Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | 8ea5c6c9-48f4-406a-a2cb-9280c546d87d | 2026-08-18 | Warnings | FZ989GH94E |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 485f0414-036f-4f42-87ee-a89543ac94c1 | 2026-08-10 | Warnings, Adverse reactions | 197701 8VZV102JFY |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 7961c029-746c-48c3-888b-8f8344102873 | 2026-07-30 | Warnings, Adverse reactions | 197700 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | c89c3bbd-1170-4170-e053-2a95a90a8e41 | 2026-07-29 | Warnings, Adverse reactions | ANDA077253 197699 8VZV102JFY |
| GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS | POLYVINYL ALCOHOL, POVIDONE | AmerisourceBergen | ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f | 2026-07-22 | Warnings | FZ989GH94E |
| Fluconazole | FLUCONAZOLE | Redpharm Drug | 568d9f2f-3394-b972-e063-6394a90a8628 | 2026-07-14 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 6bb386b0-9dbe-40ee-b873-5215b1905920 | 2026-07-14 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| FLUCONAZOLE | FLUCONAZOLE | HAWAII REPACK, INC. | 8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8 | 2026-07-03 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | 126406ae-1fdc-df20-e063-6294a90a2718 | 2026-06-29 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 67af604c-928f-468b-ba27-ad45e95d3e7e | 2026-06-24 | Warnings, Adverse reactions | 197698 8VZV102JFY |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 7259671f-a703-4a2a-81db-9a4839b34072 | 2026-06-24 | Warnings, Adverse reactions | 197700 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a995790a-8470-4c51-801a-69347151a6fe | 2026-06-24 | Warnings, Adverse reactions | 197698 8VZV102JFY |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.