Dilantin-125 (phenytoin) NDC 58151-115

NDC codes

FDA NDC Directory

Product NDC (as listed)58151-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58151-0115Add 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
58151-115-35	58151011535	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTICMarketed from Apr 19, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Dilantin-125
Generic name (nonproprietary): phenytoin
Active ingredients: Phenytoin — 125 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 008762
Marketing start: Apr 19, 2024
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 58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277SPL ID f339f9e4-b289-4efe-82b9-46c57d1dc277SPL set ID f339f9e4-b289-4efe-82b9-46c57d1dc277RxCUI 1313112, 1313884UNII 6158TKW0C5
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

N458151011535 followed by a unit qualifier and the quantity

Package 58151-0115-35. 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 Feb 2, 2023.

Indications (excerpt from the label)

DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 008762

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

FDA NDC Directory listings under NDA 008762
Product	Strength	Form · route	Labeler	Product NDC
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	Mylan Pharmaceuticals Inc.	59762-0531