Prescription drug · ANDA
Armodafinil NDC 72189-133
Armodafinil 250 mg/1 · Tablet · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-133-30 | 72189013330 | 30 TABLET in 1 BOTTLE (72189-133-30)Marketed from Oct 15, 2020 |
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 — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- direct rx
- 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 72189-133_2c28fdcb-8329-f51c-e063-6394a90a2fe2SPL ID 2c28fdcb-8329-f51c-e063-6394a90a2fe2SPL set ID b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19RxCUI 724861UNII 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
N472189013330followed by a unit qualifier and the quantityPackage 72189-0133-30. 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)
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.
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 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-805 |
| Armodafinil | Armodafinil 150 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-806 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-807 |
| 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 |