Prescription drug · ANDA
Phenytoin Sodium NDC 70518-0107
Phenytoin sodium 100 mg/1 · Capsule, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0107-0 | 70518010700 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-0107-0)Marketed from Jan 6, 2017 |
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
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-0107_522c4ffd-8073-6be5-e063-6294a90ac6c9SPL ID 522c4ffd-8073-6be5-e063-6294a90ac6c9SPL set ID e33ce05d-9c60-4ede-8b13-e8c41a3de25dRxCUI 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
N470518010700followed by a unit qualifier and the quantityPackage 70518-0107-00. 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)
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.
About NDC 70518-0107
- What is NDC 70518-0107?
- 70518-0107 is the product NDC for Phenytoin Sodium, Phenytoin sodium 100 mg/1 capsule, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenytoin Sodium.
- What is the active ingredient?
- Phenytoin sodium.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenytoin Sodium?
- 26 other product NDCs are listed under this name. See all Phenytoin Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenytoin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-0585 | 67046-0585-03 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | AvPAK | 50268-719 | 50268-0719-13 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Major Pharmaceuticals | 0904-7416 | 00904-7416-61 |
| Phenytoin Sodium | Phenytoin sodium 50 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9808 | 00404-9808-05 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-379 | 29300-0379-0129300-0379-0529300-0379-10 |
| Phenytoin Sodium | Phenytoin sodium 50 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9932 | 00404-9932-02 |
| Phenytoin Sodium | Phenytoin sodium 50 mg/mL | InjectionIntramuscular, Intravenous | Acella Pharmaceuticals, LLC | 42192-614 | 42192-0614-1042192-0614-30 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-2293 | 70518-2293-0070518-2293-01 |
| Phenytoin Sodium | Phenytoin sodium 50 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1250 | 51662-1250-01 |
| Phenytoin Sodium | Phenytoin sodium 50 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1251 | 51662-1251-0151662-1251-03 |
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 | 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 | Proficient Rx LP | 82804-269 |
| 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 | Major Pharmaceuticals | 0904-7416 |
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | Capsule, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-934 |
| 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 |