Modafinil
- Modafinil MODAFINIL 100 mg/1 Aurobindo Pharma Limited
- Modafinil MODAFINIL 100 mg/1 Major Pharmaceuticals
- Modafinil MODAFINIL 100 mg/1 CIMA LABS INC.
- Modafinil MODAFINIL 100 mg/1 CIMA LABS INC.
- Modafinil MODAFINIL 100 mg/1 Apotex Corp.
- Modafinil MODAFINIL 100 mg/1 American Health Packaging
- Provigil MODAFINIL 100 mg/1 Cephalon, LLC
- Modafinil MODAFINIL 100 mg/1 Major Pharmaceuticals
- Modafinil MODAFINIL 100 mg/1 Bryant Ranch Prepack
- Modafinil MODAFINIL 100 mg/1 Alembic Pharmaceuticals Inc.
- Modafinil MODAFINIL 100 mg/1 Proficient Rx LP
- Modafinil MODAFINIL 100 mg/1 CIMA LABS INC.
- Provigil MODAFINIL 100 mg/1 Cephalon, LLC
- Modafinil MODAFINIL 100 mg/1 Rising Health, LLC
- Modafinil MODAFINIL 100 mg/1 Alembic Pharmaceuticals Limited
- Modafinil MODAFINIL 100 mg/1 Zydus Lifesciences Limited
- Modafinil MODAFINIL 100 mg/1 Bryant Ranch Prepack
- Modafinil MODAFINIL 100 mg/1 Viona Pharmaceuticals Inc
- Modafinil MODAFINIL 100 mg/1 Bionpharma Inc.
Summary of product characteristics
Effective Time
20231004
Version
5
Spl Product Data Elements
Modafinil Modafinil MODAFINIL MODAFINIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN OFF-WHITE CAPSULE 1072 Modafinil Modafinil MODAFINIL MODAFINIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN OFF-WHITE CAPSULE 10;73
Application Number
ANDA209966
Brand Name
Modafinil
Generic Name
Modafinil
Product Ndc
70771-1051
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1051-3 Modafinil Tablets USP, 100 mg 30 Tablets Rx only NDC 70771-1052-3 Modafinil Tablets USP, 200 mg 30 Tablets Rx only Modafinil Tablets USP, 100mg and 200mg Modafinil Tablets USP, 100mg and 200mg
Spl Medguide
SPL MEDGUIDE
Drug section
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.