Prescription drug · ANDA
Modafinil NDC 71335-2258
Modafinil 200 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2258-0 | 71335225800 | 100 TABLET in 1 BOTTLE (71335-2258-0)Marketed from Apr 3, 2024 | |
| 71335-2258-1 | 71335225801 | 30 TABLET in 1 BOTTLE (71335-2258-1)Marketed from Nov 2, 2023 | |
| 71335-2258-2 | 71335225802 | 18 TABLET in 1 BOTTLE (71335-2258-2)Marketed from Apr 3, 2024 | |
| 71335-2258-3 | 71335225803 | 16 TABLET in 1 BOTTLE (71335-2258-3)Marketed from Apr 3, 2024 | |
| 71335-2258-4 | 71335225804 | 8 TABLET in 1 BOTTLE (71335-2258-4)Marketed from Apr 3, 2024 | |
| 71335-2258-5 | 71335225805 | 10 TABLET in 1 BOTTLE (71335-2258-5)Marketed from Apr 3, 2024 | |
| 71335-2258-6 | 71335225806 | 60 TABLET in 1 BOTTLE (71335-2258-6)Marketed from Oct 26, 2023 | |
| 71335-2258-7 | 71335225807 | 90 TABLET in 1 BOTTLE (71335-2258-7)Marketed from Apr 3, 2024 | |
| 71335-2258-8 | 71335225808 | 45 TABLET in 1 BOTTLE (71335-2258-8)Marketed from Apr 3, 2024 | |
| 71335-2258-9 | 71335225809 | 180 TABLET in 1 BOTTLE (71335-2258-9)Marketed from Apr 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207196
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71335-2258_1edff16c-5323-43d1-9896-dfc4a4ebf243SPL ID 1edff16c-5323-43d1-9896-dfc4a4ebf243SPL set ID dd1454b3-8599-4dfa-aaf7-b8a3ebe85acdRxCUI 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
N471335225800followed by a unit qualifier and the quantityPackage 71335-2258-00. 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 207196
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 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2501 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-605 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-862 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8653 |