Prescription drug · ANDA
Phenytek (Extended phenytoin sodium) NDC 0378-2670
Phenytoin sodium 200 mg/1 · Capsule, Extended release · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2670-01 | 0037826700100378267001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)Marketed from Dec 10, 2001 | |
| 0378-2670-93 | 0037826709300378267093 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-93)Marketed from Dec 10, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Phenytek
- Generic name (nonproprietary)
- extended phenytoin sodium
- Active ingredients
- Phenytoin sodium — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- 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 0378-2670_a532ea94-0186-4554-969c-66ff80f95c94SPL ID a532ea94-0186-4554-969c-66ff80f95c94SPL set ID 0f94c791-8b07-4b41-927e-c9f28bec5f60RxCUI 855861, 855863, 855873, 855875UNII 4182431BJHUPC 0303783750934, 0303782670936
- 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
N400378267001followed by a unit qualifier and the quantityPackage 00378-2670-01. 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)
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 0378-2670
- What is NDC 0378-2670?
- 0378-2670 is the product NDC for Phenytek (extended phenytoin sodium), Phenytoin sodium 200 mg/1 capsule, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 | Coupler LLC | 67046-1486 | 67046-1486-03 |
| 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 |
|---|---|---|---|---|
| Phenytekphenytoin sodium | Phenytoin sodium 300 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-3750 |
| Phenytekextended phenytoin sodium | Phenytoin sodium 200 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-1486 |