Dilantin (extended phenytoin sodium) NDC 70518-4325

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4325Add 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
70518-4325-0	70518432500	100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)Marketed from Apr 2, 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): Dilantin
Generic name (nonproprietary): extended phenytoin sodium
Active ingredients: Phenytoin sodium — 30 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084349
Marketing start: Apr 2, 2025
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 70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9SPL ID 402f06b8-06fa-e2d6-e063-6294a90ad8c9SPL set ID db8c69b0-4697-433e-98c7-b0b2d2c52a83RxCUI 855869, 855871UNII 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

N470518432500 followed by a unit qualifier and the quantity

Package 70518-4325-00. 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 2, 2025.

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	Viatris Specialty LLC	58151-118
Dilantinextended phenytoin sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Viatris Specialty LLC	58151-110