Prescription drug · NDA
Provigil (Modafinil) NDC 60505-4852
Modafinil 200 mg/1 · Tablet · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4852-3 | 6050548520360505485203 | 30 TABLET in 1 BOTTLE (60505-4852-3)Marketed from Aug 31, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Apotex CorpNDC labeler code 60505
- 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 60505-4852_ff96d3ff-6a1c-2545-b939-f383e0262179SPL ID ff96d3ff-6a1c-2545-b939-f383e0262179SPL set ID 0391f182-1958-9fef-a944-53b229ce99e7RxCUI 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
N460505485203followed by a unit qualifier and the quantityPackage 60505-4852-03. 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.
About NDC 60505-4852
- What is NDC 60505-4852?
- 60505-4852 is the product NDC for Provigil (modafinil), Modafinil 200 mg/1 tablet, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Provigil (Modafinil).
- What is the active ingredient?
- Modafinil.
- Who is the labeler?
- Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Provigil?
- 3 other product NDCs are listed under this name. See all Provigil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Provigil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Apotex Corp | 60505-4851 | 60505-4851-03 |
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-009 | 60429-0009-30 |
| Provigilmodafinil | Modafinil 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-010 | 60429-0010-30 |
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 |
|---|---|---|---|---|
| modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-925 |
| 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 | Golden State Medical Supply, Inc. | 60429-009 |
| Provigilmodafinil | Modafinil 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-010 |
| Provigilmodafinil | Modafinil 100 mg/1 | TabletOral | Apotex Corp | 60505-4851 |