Prescription drug · NDA
Nuvigil (Armodafinil) NDC 63459-215
Armodafinil 150 mg/1 · Tablet · Oral · Cephalon, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63459-215-30 | 6345902153063459021530 | 30 TABLET in 1 BOTTLE (63459-215-30)Marketed from Jan 3, 2011 |
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)
- Nuvigil
- Generic name (nonproprietary)
- armodafinil
- Active ingredients
- Armodafinil — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cephalon, LLCNDC labeler code 63459
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021875
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Identifiers
- Product ID 63459-215_a70488d7-57ea-446e-89c2-87b0ecc90023SPL ID a70488d7-57ea-446e-89c2-87b0ecc90023SPL set ID d878aed0-ddbf-8fa1-abf7-d3e480260845RxCUI 724859, 724861, 724863, 805659, 805661, 805663, 861960, 861962UNII V63XWA605I
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
N463459021530followed by a unit qualifier and the quantityPackage 63459-0215-30. 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)
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL 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 NUVIGIL for excessive sleepiness. NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorde…
Excerpt only. Read the full label for complete information.
About NDC 63459-215
- What is NDC 63459-215?
- 63459-215 is the product NDC for Nuvigil (armodafinil), Armodafinil 150 mg/1 tablet, listed with the FDA by Cephalon, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nuvigil (Armodafinil).
- What is the active ingredient?
- Armodafinil.
- Who is the labeler?
- Cephalon, LLC, NDC labeler code 63459. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nuvigil?
- 8 other product NDCs are listed under this name. See all Nuvigil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nuvigil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Apotex Corp. | 60505-4846 | 60505-4846-03 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Apotex Corp. | 60505-4847 | 60505-4847-03 |
| Nuvigilarmodafinil | Armodafinil 200 mg/1 | TabletOral | Apotex Corp. | 60505-4849 | 60505-4849-03 |
| Nuvigilarmodafinil | Armodafinil 250 mg/1 | TabletOral | Apotex Corp. | 60505-4850 | 60505-4850-03 |
| Nuvigilarmodafinil | Armodafinil 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-003 | 60429-0003-30 |
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-001 | 60429-0001-30 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-002 | 60429-0002-30 |
| Nuvigilarmodafinil | Armodafinil 250 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-004 | 60429-0004-30 |
Other NDCs under NDA 021875
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 |
|---|---|---|---|---|
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3090 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3092 |
| Nuvigilarmodafinil | Armodafinil 250 mg/1 | TabletOral | Apotex Corp. | 60505-4850 |
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Sandoz Inc | 0781-8029 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Quality Care Products LLC | 55700-510 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-261 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Sandoz Inc | 0781-8037 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Sandoz Inc | 0781-8045 |
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-001 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-002 |
| Nuvigilarmodafinil | Armodafinil 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-003 |
| Nuvigilarmodafinil | Armodafinil 250 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-004 |
| Nuvigilarmodafinil | Armodafinil 200 mg/1 | TabletOral | Apotex Corp. | 60505-4849 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3094 |
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Apotex Corp. | 60505-4846 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Apotex Corp. | 60505-4847 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | DirectRx | 72189-353 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Sandoz Inc | 0781-8053 |