Phenytek (phenytoin sodium) NDC 0378-3750

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3750Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3750Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-3750-01	00378375001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)Marketed from Dec 10, 2001
0378-3750-93	00378375093	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)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): phenytoin sodium
Active ingredients: Phenytoin sodium — 300 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040298
Marketing start: Dec 10, 2001
Listing expires: Dec 31, 2026
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 0378-3750_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

N400378375001 followed by a unit qualifier and the quantity

Package 00378-3750-01. 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 Oct 15, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040298

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040298
Product	Strength	Form · route	Labeler	Product NDC
Phenytekextended phenytoin sodium	Phenytoin sodium 200 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-1486
Phenytekextended phenytoin sodium	Phenytoin sodium 200 mg/1	Capsule, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-2670