Quick answers
- What is Modafinil used for?
- The FDA-approved label (Provigil, Golden State Medical Supply, Inc., October 16, 2025) says: “PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Modafinil have a boxed warning?
- No. None of the 35 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Modafinil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Modafinil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Modafinil?
- 21 companies list prescription products of Modafinil in the FDA NDC Directory, including Aphena Pharma Solutions - Tennessee, LLC, Golden State Medical Supply, Inc. and Bryant Ranch Prepack.
What Modafinil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. …
— FDA label: Provigil, Golden State Medical Supply, Inc., effective October 16, 2025. Read the full label on DailyMed →
The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 56 in the FDA NDC Directory |
| Brand names | Provigil |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| modafinil 100 mg tablet | Generic | $0.2539 per tablet |
| modafinil 100 mg tablet | Brand: Provigil | $53.18 per tablet |
| modafinil 200 mg tablet | Generic | $0.3526 per tablet |
| modafinil 200 mg tablet | Brand: Provigil | $80.25 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aphena Pharma Solutions - Tennessee, LLC6 products
- Golden State Medical Supply, Inc.5 products
- Bryant Ranch Prepack5 products
- Asclemed USA, Inc.4 products
- Apotex Corp.4 products
- Proficient Rx LP3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Alembic Pharmaceuticals Inc.2 products
- Zydus Lifesciences Limited2 products
- Alembic Pharmaceuticals Limited2 products
- AvPAK2 products
- Preferred Pharmaceuticals Inc.2 products
- Viona Pharmaceuticals Inc2 products
- Cima Labs Inc.2 products
- Aurobindo Pharma Limited2 products
- Major Pharmaceuticals2 products
- Bionpharma Inc.2 products
- American Health Packaging2 products
- Rising Pharma Holdings, Inc.2 products
- NuCare Pharmaceuticals, Inc.1 product
- Cephalon, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020717 PROVIGIL | Nuvo Pharms | December 24, 1998 | 29, latest January 15, 2015 2015: Labeling · 2015: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (6)
- ANDA078963Orbion Pharms · September 26, 2012
- ANDA202566Aurobindo Pharma Ltd · September 27, 2012
- ANDA202700Alembic · October 18, 2012
- ANDA077667Apotex · February 3, 2014
- ANDA207196Appco · August 16, 2017
- ANDA209966Cadila · September 14, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 205324, 213471, 226426, 260218 |
|---|---|
| SPL set ID of the quoted label | 3b8d1c32-dac9-50e6-e063-6394a90aa5a5 |
| FDA labels (SPL) | 35 |
| FDA applications | NDA020717, 6 ANDA |
| Active ingredients (FDA) | MODAFINIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Provigil, Golden State Medical Supply, Inc., effective October 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →