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 |
|---|---|---|---|---|---|---|
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | 368GB5141J |
| Modafinil | MODAFINIL | Proficient Rx LP | d97684d7-c236-451e-99bd-b8df4bf36643 | 2023-06-01 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | CIMA LABS INC. | 9f3b0bd2-72a3-411f-aeec-b533373f1a97 | 2023-01-31 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Aphena Pharma Solutions - Tennessee, LLC | a4a27496-0f5a-4ea8-b48c-72fcb323dc8f | 2023-01-16 | Warnings, Adverse reactions | R3UK8X3U3D |
| Petrochemical Detox | CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANS | Deseret Biologicals, Inc. | b38b492a-cf45-4aa2-ba7e-4573d2c4ebe5 | 2023-01-12 | Warnings | 368GB5141J |
| 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 | R3UK8X3U3D |
| Modafinil | MODAFINIL | Alembic Pharmaceuticals Limited | 5b8496fe-b647-4ce6-aeef-71245712e46f | 2022-06-03 | Warnings, Adverse reactions | R3UK8X3U3D |
| Modafinil | MODAFINIL | Alembic Pharmaceuticals Inc. | 41f9ddbd-5228-4f0c-b0aa-2056af79a21e | 2021-10-01 | Warnings, Adverse reactions | R3UK8X3U3D |
| 820cdf60-3664-42fc-a17f-85f5b1894551 | 3bf643a3-ca5d-43bd-9b83-865fa5d4eb08 | 2019-08-26 | Warnings, Adverse reactions | 820cdf60-3664-42fc-a17f-85f5b1894551 3bf643a3-ca5d-43bd-9b83-865fa5d4eb08 | ||
| modafinil | MODAFINIL | Aphena Pharma Solutions - Tennessee, LLC | cad4201c-133c-4a61-9d93-3c5e51695430 | 2017-12-19 | Warnings, Adverse reactions | R3UK8X3U3D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.