Dilantin (extended phenytoin sodium) NDC 58151-110

NDC codes

FDA NDC Directory

Product NDC (as listed)58151-110Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58151-0110Add 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
58151-110-01	58151011001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)Marketed from Dec 6, 2024
58151-110-10	58151011010	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)Marketed from Apr 9, 2025
58151-110-88	58151011088	100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)Marketed from Dec 6, 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
Generic name (nonproprietary): extended phenytoin sodium
Active ingredients: Phenytoin sodium — 100 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084349
Marketing start: Dec 6, 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 58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3SPL ID 872f23a8-e6a3-4038-922d-0c26fc81d8b3SPL set ID 86dd27d1-9cee-48ae-b55d-e2d2f7dbc593RxCUI 855671, 855673, 855869, 855871UNII 4182431BJHUPC 0358151118014, 0358151110018
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

N458151011001 followed by a unit qualifier and the quantity

Package 58151-0110-01. 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 Aug 21, 2023.

Indications (excerpt from the label)

DILANTIN is 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. DILANTIN is 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 084349

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

FDA NDC Directory listings under ANDA 084349
Product	Strength	Form · route	Labeler	Product NDC
Dilantinextended phenytoin sodium	Phenytoin sodium 30 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4325
Dilantinextended phenytoin sodium	Phenytoin sodium 30 mg/1	Capsule, Extended releaseOral	Viatris Specialty LLC	58151-118