What is NDC 0904-7416?

0904-7416 is the product NDC for Phenytoin Sodium, Phenytoin sodium 100 mg/1 capsule, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Major Pharmaceuticals, NDC labeler code 0904. 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 0904-7416 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7416Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7416Add 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
0904-7416-61	0090474166100904741661	100 BLISTER PACK in 1 CARTON (0904-7416-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 9, 2025

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 — 100 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040684
Marketing start: Dec 9, 2025
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 0904-7416_a7a4bd3b-c662-41c8-88f7-575968f2eb6bSPL ID a7a4bd3b-c662-41c8-88f7-575968f2eb6bSPL set ID 46d5c0d1-a97b-46d9-8cf4-994780673337RxCUI 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

N400904741661 followed by a unit qualifier and the quantity

Package 00904-7416-61. 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 20, 2026.

Indications (excerpt from the label)

Extended phenytoin sodium capsules are 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. Extended phenytoin sodium capsules are 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)

About NDC 0904-7416

What is NDC 0904-7416?: 0904-7416 is the product NDC for Phenytoin Sodium, Phenytoin sodium 100 mg/1 capsule, extended release, listed with the FDA by Major Pharmaceuticals. 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?: Major Pharmaceuticals, NDC labeler code 0904. 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 50 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9808	00404-9808-05
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 040684

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

FDA NDC Directory listings under ANDA 040684
Product	Strength	Form · route	Labeler	Product NDC
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-3539
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-5700
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	AvPAK	50268-719
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Golden State Medical Supply, Inc.	51407-982
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	51672-4111
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0585
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-0107
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-2293
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-869
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-934
Phenytoin Sodium	Phenytoin sodium 100 mg/1	Capsule, Extended releaseOral	Proficient Rx LP	82804-269