What is NDC 42192-614?

42192-614 is the product NDC for Phenytoin Sodium, Phenytoin sodium 50 mg/mL injection, listed with the FDA by Acella Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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 42192-614 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42192-614Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42192-0614Add 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
42192-614-10	42192061410	10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIALMarketed from Dec 30, 2021
42192-614-30	42192061430	10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIALMarketed from Dec 30, 2021

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 — 50 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Acella Pharmaceuticals, LLCNDC labeler code 42192
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040573
Marketing start: Dec 1, 2021
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 42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2SPL ID ae14cce7-f65a-45e0-8ff4-9388d0a806d2SPL set ID 6922f32f-8bed-4c09-8103-27987bcbd104RxCUI 1670351, 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

N442192061410 followed by a unit qualifier and the quantity

Package 42192-0614-10. 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 Sep 16, 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 Sodium Injection 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 substitute…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42192-614

What is NDC 42192-614?: 42192-614 is the product NDC for Phenytoin Sodium, Phenytoin sodium 50 mg/mL injection, listed with the FDA by Acella Pharmaceuticals, LLC. It has 2 package NDCs, 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?: Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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 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 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