Prescription drug · ANDA
Modafinil NDC 71335-1122
Modafinil 100 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1122-1 | 71335112201 | 30 TABLET in 1 BOTTLE (71335-1122-1)Marketed from Feb 26, 2019 | |
| 71335-1122-2 | 71335112202 | 60 TABLET in 1 BOTTLE (71335-1122-2)Marketed from Mar 14, 2019 | |
| 71335-1122-3 | 71335112203 | 28 TABLET in 1 BOTTLE (71335-1122-3)Marketed from Mar 14, 2019 | |
| 71335-1122-4 | 71335112204 | 90 TABLET in 1 BOTTLE (71335-1122-4)Marketed from Mar 14, 2019 | |
| 71335-1122-5 | 71335112205 | 45 TABLET in 1 BOTTLE (71335-1122-5)Marketed from Jul 9, 2024 | |
| 71335-1122-6 | 71335112206 | 180 TABLET in 1 BOTTLE (71335-1122-6)Marketed from Jul 9, 2024 | |
| 71335-1122-7 | 71335112207 | 100 TABLET in 1 BOTTLE (71335-1122-7)Marketed from Dec 12, 2022 |
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 — 100 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 202566
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71335-1122_0c6f0c70-8e9e-4d04-bd7d-88bc33255611SPL ID 0c6f0c70-8e9e-4d04-bd7d-88bc33255611SPL set ID f1ff7c6d-df04-48dd-a971-454d38e7d997RxCUI 260218UNII 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
N471335112201followed by a unit qualifier and the quantityPackage 71335-1122-01. 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 202566
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 | Aurobindo Pharma Limited | 65862-601 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Proficient Rx LP | 71205-544 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-602 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-307 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-306 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5121 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | AvPAK | 50268-570 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | AvPAK | 50268-571 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | American Health Packaging | 68084-621 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | American Health Packaging | 68084-721 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Proficient Rx LP | 71205-477 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1173 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7315 |
| Modafinil | Modafinil 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-154 |
| Modafinil | Modafinil 200 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-155 |