NDC 0378-5575-01 - Modafinil
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
- 0378-5575
- Requested NDC
- 0378-5575-01
- Package NDCs from labels
- 0378-5575-93, 0378-5575-05, 0378-5575-01
- Manufacturer
- Mylan Institutional Inc.
- Effective date
- 2019-11-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Modafinil - Mylan Institutional Inc. | Mylan Institutional Inc. | 2019-11-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Modafinil - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2019-10-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Modafinil - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2016-03-17 | HUMAN PRESCRIPTION DRUG LABEL |
| Modafinil - Aphena Pharma Solutions - Tennessee, LLC | Aphena Pharma Solutions - Tennessee, LLC | 2014-04-03 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2013-02-13 | Indexing - Billing Unit |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-5575-01 | EA - Each | 0378-5575 | c1aa9f9a-3b66-4f85-a554-b2a0ea9a3399 | 1 | 2013-02-13 |
| 0378-5575-05 | EA - Each | 0378-5575 | f12cf010-198e-40b0-b820-3eab9c75c678 | 1 | 2013-02-13 |
| 0378-5575-93 | EA - Each | 0378-5575 | e79ed0aa-9321-4f3a-b19a-6a10905d27f0 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Modafinil | MODAFINIL | Bryant Ranch Prepack | 963aa6be-5aed-4865-b375-8c2c3102e7bc | 2024-08-27 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Zydus Lifesciences Limited | f39820fb-8248-4d42-854c-6fe2d9b92d36 | 2024-08-16 | 205324 R3UK8X3U3D | |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | f1ff7c6d-df04-48dd-a971-454d38e7d997 | 2024-07-09 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | f0c43046-fc86-4b62-bd0f-704a6894625d | 2024-07-08 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Proficient Rx LP | c332ea93-48d9-4c8a-a1ef-01c27a61350b | 2024-07-01 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | NuCare Pharmaceuticals,Inc. | 98e54b10-8ae0-7c43-e053-2a95a90ae8bb | 2024-06-20 | Warnings, Adverse reactions | R3UK8X3U3D |
| Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | NuCare Pharmaceuticals,Inc. | 9c1c4911-908e-3c3c-e053-2995a90abcfc | 2024-06-14 | Warnings | FZ989GH94E |
| Modafinil | MODAFINIL | Rising Pharma Holdings, Inc. | 4b63aac6-4385-44a3-8390-cdbb0b4b5fe0 | 2024-05-27 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Aurobindo Pharma Limited | f51ca007-3955-4540-a88a-0ddae8d8e8ab | 2024-05-27 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | dd1454b3-8599-4dfa-aaf7-b8a3ebe85acd | 2024-04-03 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Clear Eyes Natural Tears | POLYVINYL ALCOHOL AND POVIDONE | Prestige Brands Holdings, Inc. | efba3eb0-798d-4635-b19b-4970e45b3cc9 | 2024-04-01 | Warnings | FZ989GH94E |
| REFRESH CLASSIC | POLYVINYL ALCOHOL, POVIDONE | A-S Medication Solutions | 3bf6193c-56db-45ad-844c-58eb8c33cba9 | 2024-03-14 | Warnings | FZ989GH94E |
| 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 |
| 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 |
| Meijer Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Meijer Distribution, Inc. | 9feb3eec-a36f-8fc7-e053-2a95a90adcd3 | 2023-12-22 | Warnings | FZ989GH94E |
| Meijer Advanced Redness and Irritation Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI | Meijer Distribution, Inc. | 9fea6d7a-a2cd-d26e-e053-2995a90a15f8 | 2023-12-22 | Warnings | FZ989GH94E |
| Walgreens Eye Drops Advanced Relief 15mL | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI | Walgreen Company | 949f5560-fba7-2da8-e053-2995a90a23c2 | 2023-12-20 | Warnings | FZ989GH94E |
| Signature Care Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Better Living Brands LLC | 5d7228ce-f108-4cc2-9aec-8b4548c3a155 | 2023-12-20 | Warnings | FZ989GH94E |
| Kroger Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Kroger Company | f7ad77fc-d890-25b9-e053-6394a90a2b12 | 2023-12-20 | Warnings | FZ989GH94E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.