Prescription drug · ANDA
Armodafinil NDC 65862-805
Armodafinil 50 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-805-05 | 65862080505 | 500 TABLET in 1 BOTTLE (65862-805-05)Marketed from Mar 6, 2018 | |
| 65862-805-30 | 65862080530 | 30 TABLET in 1 BOTTLE (65862-805-30)Marketed from Mar 6, 2018 | |
| 65862-805-60 | 65862080560 | 60 TABLET in 1 BOTTLE (65862-805-60)Marketed from Mar 6, 2018 |
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)
- Armodafinil
- Generic name (nonproprietary)
- armodafinil
- Active ingredients
- Armodafinil — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206069
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 65862-805_09746c0a-9656-4f1d-a380-1cbe732c8e21SPL ID 09746c0a-9656-4f1d-a380-1cbe732c8e21SPL set ID 23da56b8-7552-4362-a1ab-e794c131194cRxCUI 724859, 724861, 724863, 861960UNII V63XWA605IUPC 0365862807304, 0365862805300
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
N465862080505followed by a unit qualifier and the quantityPackage 65862-0805-05. 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 ANDA 206069
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 | Direct_Rx | 72189-464 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-806 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-807 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | direct rx | 72189-133 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1193 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7826 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7880 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-998 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1308 |