Prescription drug · ANDA
Modafinil NDC 71610-989
Modafinil 200 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-989-30 | 71610098930 | 30 TABLET in 1 BOTTLE (71610-989-30)Marketed from Feb 10, 2026 | |
| 71610-989-53 | 71610098953 | 60 TABLET in 1 BOTTLE (71610-989-53)Marketed from Feb 10, 2026 | |
| 71610-989-60 | 71610098960 | 90 TABLET in 1 BOTTLE (71610-989-60)Marketed from Feb 10, 2026 |
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)
- Modafinil
- Generic name (nonproprietary)
- modafinil
- Active ingredients
- Modafinil — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078963
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71610-989_4aa301e3-c34b-232a-e063-6394a90a86d1SPL ID 4aa301e3-c34b-232a-e063-6394a90a86d1SPL set ID 4aa3bdad-163f-fda1-e063-6394a90ae1d8RxCUI 205324UNII R3UK8X3U3D
- Pharmacologic class
- Sympathomimetic-like Agent
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
N471610098930followed by a unit qualifier and the quantityPackage 71610-0989-30. 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)
Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil 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 and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078963
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.