NDC 70710-1138-01 - 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
- 70710-1138
- Requested NDC
- 70710-1138-01
- Package NDCs from labels
- 70710-1138-3, 70710-1138-1, 70710-1138-5, 70710-1138-4, 70710-1138-01
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-09-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Fluconazole Tablets, USP Rx only | REMEDYREPACK INC. | 2026-09-21 | HUMAN PRESCRIPTION DRUG LABEL |
| fluconazole - Bryant Ranch Prepack | Bryant Ranch Prepack | 2026-06-24 | HUMAN PRESCRIPTION DRUG LABEL |
| fluconazole - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited | 2026-04-07 | HUMAN PRESCRIPTION DRUG LABEL |
| FLUCONAZOLE - direct rx | direct rx | 2025-01-17 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluconazole Tablets, USP Rx only | NuCare Pharmaceuticals,Inc. | 2024-06-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluconazole Tablets, USP Rx only | NuCare Pharmaceuticals,Inc. | 2023-07-14 | HUMAN PRESCRIPTION DRUG LABEL |
| fluconazole - A-S Medication Solutions | A-S Medication Solutions | 2023-02-06 | HUMAN PRESCRIPTION DRUG LABEL |
| fluconazole - Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 2021-12-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1138-1 | fluconazole | 100 in 1 BOTTLE | TABLET | 100 | 13 | |
| 70710-1138-3 | fluconazole | 30 in 1 BOTTLE | TABLET | 30 | 13 | |
| 70710-1138-4 | fluconazole | 10 in 1 CARTON | TABLET | 10 | 13 | |
| 70710-1138-4 | fluconazole | 10 in 1 BLISTER PACK | TABLET | 10 | 13 | |
| 70710-1138-5 | fluconazole | 500 in 1 BOTTLE | TABLET | 500 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1138 | FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 12 | Current NDC, Legacy NDC, 5 package rows | 20240306_d1364455-1537-46d4-b093-38cca3be778f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70710-1138-1 | EA - Each | 70710-1138 | 38c9875f-341e-4ada-9a4d-b52be786da37 | 1 | 2018-02-20 |
| 70710-1138-3 | EA - Each | 70710-1138 | e4a2ebad-6a59-4a30-a7a6-ec3db19c6e0b | 1 | 2018-02-20 |
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 | Bryant Ranch Prepack | 3f743514-615e-4e78-8321-24c545a7752f | 2024-09-06 | Warnings, Adverse reactions | 197700 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | Rising Pharma Holdings, Inc. | ccbe0991-27a1-4ddb-bfc7-1b3422e53390 | 2024-08-22 | Warnings, Adverse reactions | 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | NorthStar Rx LLC | afde17e7-b95b-4cd5-97eb-e361724014bd | 2024-08-22 | Warnings, Adverse reactions | 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | Aurobindo Pharma Limited | bf588f7e-89de-4b4e-8d33-c1ff2be1b34e | 2024-08-09 | Warnings, Adverse reactions | 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | NorthStar Rx LLC | d2acccda-8068-46c1-8562-950d7f70ee06 | 2024-07-04 | Warnings, Adverse reactions | 197698 197699 197700 197701 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | Rising Pharma Holdings, Inc. | 2ca7efcd-4a8d-4139-a3eb-930afd18b13f | 2024-07-04 | Warnings, Adverse reactions | 197698 197699 197700 197701 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | Hikma Pharmaceuticals USA Inc. | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 2024-06-28 | Warnings, Adverse reactions | 8VZV102JFY |
| Fluconazole | FLUCONAZOLE | Baxter Healthcare Company | cd24a261-9c15-42b4-8040-89d2dbda174e | 2024-06-24 | Warnings, Adverse reactions | 8VZV102JFY |
| Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | NuCare Pharmaceuticals,Inc. | 9c1c4911-908e-3c3c-e053-2995a90abcfc | 2024-06-14 | Warnings | FZ989GH94E |
| fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 715c53f0-2aea-1f24-e053-2995a90ad463 | 2024-06-10 | Warnings, Adverse reactions | ANDA208963 68071-4501-3 68071-4501 197698 1a8db552-50ac-ade6-e063-6394a90a086e 715c53f0-2aea-1f24-e053-2995a90ad463 8VZV102JFY |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | 1K09F3G675 |
| Fluconazole | FLUCONAZOLE | Pharmasource Meds, LLC | fe0cc56d-c0b6-f859-e053-6294a90ad932 | 2024-05-28 | Warnings, Adverse reactions | 197699 8VZV102JFY |
| Clear Eyes Natural Tears | POLYVINYL ALCOHOL AND POVIDONE | Prestige Brands Holdings, Inc. | efba3eb0-798d-4635-b19b-4970e45b3cc9 | 2024-04-01 | Warnings | FZ989GH94E |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
| REFRESH CLASSIC | POLYVINYL ALCOHOL, POVIDONE | A-S Medication Solutions | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 2024-03-14 | Warnings | FZ989GH94E |
| fluconazole | FLUCONAZOLE | Zydus Lifesciences Limited | 0adb2f88-8a6f-4f33-9e2d-73f537e05313 | 2024-03-04 | Warnings, Adverse reactions | ANDA208963 197698 197699 197700 197701 8VZV102JFY |
| GOODSENSE ARTIFICIAL TEARS | POLYVINYL ALCOHOL | Proficient Rx LP | f29c792c-6cb2-449f-b97d-6304a58dec2a | 2024-02-01 | Warnings | FZ989GH94E |
| GoodSense Artifical Tears | POLYVINYL ALCOHOL, AND POVIDONE | Proficient Rx LP | cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9 | 2024-02-01 | Warnings | FZ989GH94E |
| Fluconazole | FLUCONAZOLE | Direct Rx | 69f199fa-bb92-4837-8b12-427a1c71f622 | 2024-01-09 | Adverse reactions | ANDA208963 197700 8VZV102JFY |
| Sunmark Eye Drops Advanced Moisturizer/Lubricant | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE | Strategic Sourcing Services LLC | 0daa4e39-0447-44b6-a7d7-370b12bf9451 | 2023-12-23 | Warnings | FZ989GH94E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.