Prescription drug · ANDA
Phenytoin Sodium NDC 71610-934
Phenytoin sodium 100 mg/1 · Capsule, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-934-92 | 71610093492 | 270 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-92)Marketed from Sep 2, 2025 | |
| 71610-934-94 | 71610093494 | 360 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-94)Marketed from Aug 6, 2025 | |
| 71610-934-98 | 71610093498 | 540 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-934-98)Marketed from Aug 18, 2025 |
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)
- Phenytoin Sodium
- Generic name (nonproprietary)
- phenytoin sodium
- Active ingredients
- Phenytoin sodium — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040684
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-934_3dd660a7-5ba3-d993-e063-6394a90aeda9SPL ID 3dd660a7-5ba3-d993-e063-6394a90aeda9SPL set ID 3bc82d23-3950-f181-e063-6394a90ad565RxCUI 855671UNII 4182431BJH
- Pharmacologic class
- Anti-epileptic 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
N471610093492followed by a unit qualifier and the quantityPackage 71610-0934-92. 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)
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040684
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 |
|---|---|---|---|---|
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-0107 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7416 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-982 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-2293 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0585 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-869 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-3539 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-719 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 82804-269 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 51672-4111 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-5700 |