Prescription drug · ANDA
Armodafinil NDC 69339-178
Armodafinil 150 mg/1 · Tablet · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-178-03 | 69339017803 | 30 TABLET in 1 BOTTLE (69339-178-03)Marketed from Mar 23, 2023 | |
| 69339-178-10 | 69339017810 | 1000 TABLET in 1 BOTTLE (69339-178-10)Marketed from Mar 23, 2023 |
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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Natco Pharma USA LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202768
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 69339-178_d93dca81-a0da-49ee-be61-86e713ab56cdSPL ID d93dca81-a0da-49ee-be61-86e713ab56cdSPL set ID de2f0921-e791-426c-9192-2b7162e2158cRxCUI 724859, 724861, 724863, 861960UNII V63XWA605IUPC 0369339177105, 0369339180051, 0369339178102, 0369339178034, 0369339180037, 0369339179031
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
N469339017803followed by a unit qualifier and the quantityPackage 69339-0178-03. 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)
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 202768
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 | Natco Pharma USA LLC | 69339-177 |
| Armodafinil | Armodafinil 200 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-179 |
| Armodafinil | Armodafinil 250 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-180 |