Prescription drug · NDA
Provigil (modafinil) NDC 60429-010
Modafinil 200 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-010-30 | 60429001030 | 30 TABLET in 1 BOTTLE (60429-010-30)Marketed from Jul 8, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Provigil
- Generic name (nonproprietary)
- modafinil
- Active ingredients
- Modafinil — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020717
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 60429-010_414b1bd0-e6f4-2e95-e063-6394a90a5499SPL ID 414b1bd0-e6f4-2e95-e063-6394a90a5499SPL set ID 3b8d1c32-dac9-50e6-e063-6394a90aa5a5RxCUI 205324, 213471, 226426, 260218UNII R3UK8X3U3D
- Pharmacologic class
- Sympathomimetic-like Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460429001030followed by a unit qualifier and the quantityPackage 60429-0010-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the 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. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness. PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apne…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020717
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-009 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | CIMA LABS INC. | 55253-801 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | CIMA LABS INC. | 55253-802 |
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Cephalon, LLC | 63459-101 |
| Provigilmodafinil | Modafinil 200 mg/1 | TabletOral | Cephalon, LLC | 63459-201 |
| modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-925 |
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Apotex Corp | 60505-4851 |
| Provigilmodafinil | Modafinil 200 mg/1 | TabletOral | Apotex Corp | 60505-4852 |