Prescription drug · ANDA
Phenytoin Sodium NDC 51672-4111
Phenytoin sodium 100 mg/1 · Capsule, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4111-1 | 51672411101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-1)Marketed from Sep 5, 2006 | |
| 51672-4111-3 | 51672411103 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-3)Marketed from Sep 5, 2006 | |
| 51672-4111-6 | 51672411106 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4111-6)Marketed from Sep 5, 2006 |
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)
- 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 51672-4111_4d4421be-75f8-2639-e063-6294a90accd5SPL ID 4d4421be-75f8-2639-e063-6294a90accd5SPL set ID 601f7353-225d-4a5d-9810-3869c2c21874RxCUI 855671UNII 4182431BJHUPC 0351672411114
- 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
N451672411101followed by a unit qualifier and the quantityPackage 51672-4111-01. 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)
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 | A-S Medication Solutions | 50090-5700 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-934 |