Prescription drug · ANDA
Phenytek (Extended phenytoin sodium) NDC 67046-1486
Phenytoin sodium 200 mg/1 · Capsule, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1486-3 | 6704614860367046148603 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)Marketed from Jan 29, 2025 |
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)
- Phenytek
- Generic name (nonproprietary)
- extended phenytoin sodium
- Active ingredients
- Phenytoin sodium — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040298
- 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 67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7SPL ID 2cdc1905-8ef2-1275-e063-6394a90a2ab7SPL set ID 2cdc1905-8f45-1275-e063-6394a90a2ab7RxCUI 855861, 855863UNII 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
N467046148603followed by a unit qualifier and the quantityPackage 67046-1486-03. 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)
PHENYTEK ® capsules (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. PHENYTEK ® 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 67046-1486
- What is NDC 67046-1486?
- 67046-1486 is the product NDC for Phenytek (extended phenytoin sodium), Phenytoin sodium 200 mg/1 capsule, extended release, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenytek (Extended phenytoin sodium).
- What is the active ingredient?
- Phenytoin sodium.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenytek?
- 2 other product NDCs are listed under this name. See all Phenytek NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenytek products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenytekextended phenytoin sodium | Phenytoin sodium 200 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-2670 | 00378-2670-0100378-2670-93 |
| Phenytekphenytoin sodium | Phenytoin sodium 300 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-3750 | 00378-3750-0100378-3750-93 |
Other NDCs under ANDA 040298
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 |
|---|---|---|---|---|
| Phenytekextended phenytoin sodium | Phenytoin sodium 200 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-2670 |
| Phenytekphenytoin sodium | Phenytoin sodium 300 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-3750 |