Prescription drug · ANDA
Modafinil NDC 71610-685
Modafinil 200 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-685-30 | 71610068530 | 30 TABLET in 1 BOTTLE (71610-685-30)Marketed from Jan 11, 2023 | |
| 71610-685-53 | 71610068553 | 60 TABLET in 1 BOTTLE (71610-685-53)Marketed from Jan 11, 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)
- Modafinil
- Generic name (nonproprietary)
- modafinil
- Active ingredients
- Modafinil — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077667
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71610-685_e12198af-3556-407d-bac7-29b6ea6cc45fSPL ID e12198af-3556-407d-bac7-29b6ea6cc45fSPL set ID a4a27496-0f5a-4ea8-b48c-72fcb323dc8fRxCUI 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
N471610068530followed by a unit qualifier and the quantityPackage 71610-0685-30. 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.
About NDC 71610-685
- What is NDC 71610-685?
- 71610-685 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Modafinil.
- What is the active ingredient?
- Modafinil.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Modafinil?
- 50 other product NDCs are listed under this name. See all Modafinil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Modafinil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Modafinil | Modafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8653 | 68788-8653-0368788-8653-0668788-8653-09 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-862 | 23155-0862-0123155-0862-0323155-0862-05+1 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2501 | 71335-2501-0071335-2501-0171335-2501-02+7 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8280 | 68788-8280-0368788-8280-0668788-8280-09 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-989 | 71610-0989-3071610-0989-5371610-0989-60 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Bionpharma Inc. | 69452-342 | 69452-0342-1369452-0342-1969452-0342-20 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bionpharma Inc. | 69452-343 | 69452-0343-1369452-0343-1969452-0343-20 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2258 | 71335-2258-0071335-2258-0171335-2258-02+7 more |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-605 | 23155-0605-0123155-0605-0323155-0605-05+1 more |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604 | 23155-0604-0123155-0604-0323155-0604-05+1 more |
Other NDCs under ANDA 077667
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 |
|---|---|---|---|---|
| Modafinil | Modafinil 100 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6791 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6792 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-928 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Apotex Corp. | 60505-2526 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Apotex Corp. | 60505-2527 |