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 |
|---|---|---|---|---|---|---|
| Equaline Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | United Natural Foods, Inc. | f7602789-179a-edfc-e053-6294a90a0844 | 2023-12-20 | Warnings | FZ989GH94E |
| Topcare Health Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Topco Associates LLC | 9c614c0e-5862-682f-e053-2a95a90abc09 | 2023-12-20 | Warnings | FZ989GH94E |
| TopCare Health Advanced Moisturizing Plus Redness Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Topco Associates LLC | 9c6193a6-d822-1b27-e053-2995a90ab3cf | 2023-12-20 | Warnings | FZ989GH94E |
| HEB Advanced Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | HEB Grocery Company, LP | f76281d6-3aea-349b-e053-6394a90afca2 | 2023-12-20 | Warnings | FZ989GH94E |
| Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Proficient Rx LP | 73e12596-6dd5-4cd2-83ed-992e1211b4b8 | 2023-12-01 | Warnings | FZ989GH94E |
| Modafinil | MODAFINIL | Viona Pharmaceuticals Inc | 15739a31-2433-49b5-90ea-b974214f73be | 2023-11-10 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Bionpharma Inc. | 63604fef-0b80-40ce-8dbf-3384f1aee395 | 2023-07-21 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Proficient Rx LP | d97684d7-c236-451e-99bd-b8df4bf36643 | 2023-06-01 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | CIMA LABS INC. | 9f3b0bd2-72a3-411f-aeec-b533373f1a97 | 2023-01-31 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Aphena Pharma Solutions - Tennessee, LLC | a4a27496-0f5a-4ea8-b48c-72fcb323dc8f | 2023-01-16 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Proficient Rx LP | ccf7836d-c131-4e7d-a339-fbf99fe7f449 | 2023-01-01 | Warnings, Adverse reactions | R3UK8X3U3D |
| Provigil | MODAFINIL | Cephalon, LLC | e16c26ad-7bc2-d155-3a5d-da83ad6492c8 | 2022-12-31 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Alembic Pharmaceuticals Limited | 5b8496fe-b647-4ce6-aeef-71245712e46f | 2022-06-03 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Modafinil | MODAFINIL | Alembic Pharmaceuticals Inc. | 41f9ddbd-5228-4f0c-b0aa-2056af79a21e | 2021-10-01 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | L11K75P92J |
| MEDULLOSSEINUM PLEX | ARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE | Seroyal USA | 22b7eafe-ef76-0677-e054-00144ff88e88 | 2020-10-09 | Warnings | L11K75P92J |
| 60c4da65-7554-4b45-a444-120b79988be9 | c8101f2f-c05f-445d-a2ed-cfbff84de070 | 2020-07-27 | Warnings, Adverse reactions | c8101f2f-c05f-445d-a2ed-cfbff84de070 | ||
| 96c2ee5a-0754-7774-e053-2995a90ad6fc | 1f89a085-c937-4e77-9e90-fb04536cb460 | 2019-11-07 | Warnings, Adverse reactions | 96c2ee5a-0754-7774-e053-2995a90ad6fc 1f89a085-c937-4e77-9e90-fb04536cb460 | ||
| modafinil | MODAFINIL | Aphena Pharma Solutions - Tennessee, LLC | cad4201c-133c-4a61-9d93-3c5e51695430 | 2017-12-19 | Warnings, Adverse reactions | 205324 R3UK8X3U3D |
| f95ebc11-320c-4520-8268-9141128b1ffe | f3b3097f-80b8-4410-af21-dcdea144e3c3 | 2016-03-17 | Warnings, Adverse reactions | f3b3097f-80b8-4410-af21-dcdea144e3c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.