Phenytoin Sodium NDC 61919-815

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-815Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0815Add 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
61919-815-30	61919081530	30 CAPSULE in 1 BOTTLE (61919-815-30)Marketed from Jan 1, 2014
61919-815-71	61919081571	100 CAPSULE in 1 BOTTLE (61919-815-71)Marketed from Jan 1, 2014
61919-815-72	61919081572	120 CAPSULE in 1 BOTTLE (61919-815-72)Marketed from Jan 1, 2014

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): Phenytoin Sodium
Generic name (nonproprietary): phenytoin sodium
Active ingredients: Phenytoin sodium — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: DIRECT RX
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040765
Marketing start: Jan 1, 2014
Listing expires: Dec 31, 2027
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 61919-815_4bd28a50-22df-5238-e063-6294a90a6eecSPL ID 4bd28a50-22df-5238-e063-6294a90a6eecSPL set ID df0bf42b-ce9a-42c3-8c24-46f1ea3bd214RxCUI 855671UNII 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

N461919081530 followed by a unit qualifier and the quantity

Package 61919-0815-30. 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 27, 2026.

Indications (excerpt from the label)

INDICATIONS & USAGE SECTION Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040765

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

FDA NDC Directory listings under ANDA 040765
Product	Strength	Form · route	Labeler	Product NDC
Extended Phenytoin Sodiumphenytoin sodium	Phenytoin sodium 100 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-212