Prescription drug · NDA AUTHORIZED GENERIC
Armodafinil NDC 0781-8045
Armodafinil 200 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-8045-31 | 00781804531 | 30 TABLET in 1 BOTTLE (0781-8045-31)Marketed from Dec 1, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Armodafinil
- Generic name (nonproprietary)
- armodafinil
- Active ingredients
- Armodafinil — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021875
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Identifiers
- Product ID 0781-8045_dea0ad34-a35f-42ba-a6b6-dea58a16868fSPL ID dea0ad34-a35f-42ba-a6b6-dea58a16868fSPL set ID a3341ec8-1ad4-49e2-922b-13d1b30c8c1dRxCUI 724859, 724861, 724863, 861960UNII 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
N400781804531followed by a unit qualifier and the quantityPackage 00781-8045-31. 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)
Armodafinil tablets are 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, armodafinil tablets are 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 armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive s…
Excerpt only. Read the full label for complete information.
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 150 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3092 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3094 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Sandoz Inc | 0781-8037 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-002 |
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-001 |
| 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 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Sandoz Inc | 0781-8053 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Cephalon, LLC | 63459-215 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-261 |
| Nuvigilarmodafinil | Armodafinil 200 mg/1 | TabletOral | Apotex Corp. | 60505-4849 |
| Nuvigilarmodafinil | Armodafinil 50 mg/1 | TabletOral | Apotex Corp. | 60505-4846 |
| Nuvigilarmodafinil | Armodafinil 150 mg/1 | TabletOral | Apotex Corp. | 60505-4847 |
| Nuvigilarmodafinil | Armodafinil 250 mg/1 | TabletOral | Apotex Corp. | 60505-4850 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Quality Care Products LLC | 55700-510 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | DirectRx | 72189-353 |
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Sandoz Inc | 0781-8029 |
| Armodafinil | Armodafinil 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-3090 |