NDC 59115-070-01 - 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
- 59115-070
- Requested NDC
- 59115-070-01
- Package NDCs from labels
- 59115-070-01, 59115-070-09, 59115-070-30
- Manufacturer
- Hikma Pharmaceutical
- Effective date
- 2019-08-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Modafinil - Hikma Pharmaceutical | Hikma Pharmaceutical | 2019-08-26 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MODAFINIL | ACTIVE INGREDIENT | R3UK8X3U3D | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| MODAFINIL | ACTIVE MOIETY | R3UK8X3U3D | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE L) | INACTIVE INGREDIENT | UKE75GEA7F | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MODAFINIL TABLET [HIKMA PHARMACEUTICAL] | 5 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 2bc3cd03-2726-f693-e063-6294a90a7a03 | 2025-02-21 | Warnings, Adverse reactions | R3UK8X3U3D |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUM | Energique, Inc. | f3db63df-62a4-48d6-92e7-94e4a5701552 | 2024-12-20 | Warnings | 368GB5141J |
| Modafinil | MODAFINIL | American Health Packaging | 928a3ab6-b53c-4924-882c-9f2f49aba0f1 | 2024-10-31 | Warnings, Adverse reactions | R3UK8X3U3D |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | Energique, Inc. | 87c92497-8a51-4977-87fe-e0b4c6bafb19 | 2024-09-27 | Warnings | 368GB5141J |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | 3f733d7f-1213-4534-9433-0eb99a5abc2c | 2024-09-23 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | 963aa6be-5aed-4865-b375-8c2c3102e7bc | 2024-08-27 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Zydus Lifesciences Limited | f39820fb-8248-4d42-854c-6fe2d9b92d36 | 2024-08-16 | 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 | R3UK8X3U3D |
| Modafinil | MODAFINIL | Proficient Rx LP | c332ea93-48d9-4c8a-a1ef-01c27a61350b | 2024-07-01 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | NuCare Pharmaceuticals,Inc. | 98e54b10-8ae0-7c43-e053-2a95a90ae8bb | 2024-06-20 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Rising Pharma Holdings, Inc. | 4b63aac6-4385-44a3-8390-cdbb0b4b5fe0 | 2024-05-27 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Aurobindo Pharma Limited | f51ca007-3955-4540-a88a-0ddae8d8e8ab | 2024-05-27 | Warnings, Adverse reactions | R3UK8X3U3D |
| Enviroclenz | BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM | Deseret Biologicals, Inc. | 92816bbe-96d6-45fc-9929-d3e6df394a33 | 2024-05-02 | Warnings | 368GB5141J |
| Modafinil | MODAFINIL | Bryant Ranch Prepack | dd1454b3-8599-4dfa-aaf7-b8a3ebe85acd | 2024-04-03 | Warnings, Adverse reactions | R3UK8X3U3D |
| Envirotox | TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM. | BioActive Nutritional, Inc. | 2b5cfdba-cf4d-4eb0-8c60-20eac6922663 | 2024-03-26 | Warnings | 368GB5141J |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
| Modafinil | MODAFINIL | Viona Pharmaceuticals Inc | 15739a31-2433-49b5-90ea-b974214f73be | 2023-11-10 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Bionpharma Inc. | 63604fef-0b80-40ce-8dbf-3384f1aee395 | 2023-07-21 | Warnings, Adverse reactions | R3UK8X3U3D |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | BioActive Nutritional | 3382df85-3ec5-4371-830e-4ed345b8f51b | 2023-07-14 | Warnings | 368GB5141J |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.