What is NDC 0404-9808?

0404-9808 is the product NDC for Phenytoin Sodium, Phenytoin sodium 50 mg/mL injection, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Phenytoin Sodium?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenytoin Sodium NDC 0404-9808 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9808Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9808Add 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
0404-9808-05	0040498080500404980805	1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIALMarketed from Dec 26, 2024

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): Phenytoin Sodium
Generic name (nonproprietary): phenytoin sodium
Active ingredients: Phenytoin sodium — 50 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Henry Schein, Inc.NDC labeler code 0404
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084307
Marketing start: Dec 26, 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 0404-9808_5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffbSPL ID 5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffbSPL set ID a52cf1bd-dc1f-47be-aba8-29066d9a50fbRxCUI 1670353UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400404980805 followed by a unit qualifier and the quantity

Package 00404-9808-05. 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 Dec 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1, 2.3) and Warnings and Precautions (5.1)]. Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9808

What is NDC 0404-9808?: 0404-9808 is the product NDC for Phenytoin Sodium, Phenytoin sodium 50 mg/mL injection, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phenytoin Sodium.
What is the active ingredient?: Phenytoin sodium.
Who is the labeler?: Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phenytoin Sodium?: 26 other product NDCs are listed under this name. See all Phenytoin Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Phenytoin Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0585	67046-0585-03
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	AvPAK	50268-719	50268-0719-13
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Major Pharmaceuticals	0904-7416	00904-7416-61
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-379	29300-0379-0129300-0379-0529300-0379-10
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9932	00404-9932-02
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Acella Pharmaceuticals, LLC	42192-614	42192-0614-1042192-0614-30
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-2293	70518-2293-0070518-2293-01
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1250	51662-1250-01
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1251	51662-1251-0151662-1251-03
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-5700	50090-5700-0050090-5700-01

All 27 Phenytoin Sodium NDCs

Other NDCs under ANDA 084307

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

FDA NDC Directory listings under ANDA 084307
Product	Strength	Form · route	Labeler	Product NDC
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9932
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-0493
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-2555
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6138
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6139
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1250
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1251
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7079
Phenytoin Sodium	Phenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	ProPharma Distribution	84549-093