Fosphenytoin sodium NDC 68083-461

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0461Add 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
68083-461-10	68083046110	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)Marketed from Oct 13, 2023

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): Fosphenytoin sodium
Generic name (nonproprietary): fosphenytoin sodium
Active ingredients: Fosphenytoin sodium — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214926
Marketing start: Oct 13, 2023
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 68083-461_00f57b3c-3819-440e-a928-eeec0fee27aaSPL ID 00f57b3c-3819-440e-a928-eeec0fee27aaSPL set ID 49b08648-6a83-42c7-ae7b-80c29f2534fcRxCUI 1670195, 1670200UNII 7VLR55452ZUPC 0368083461010, 0368083461102, 0368083460259
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

N468083046110 followed by a unit qualifier and the quantity

Package 68083-0461-10. 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 Oct 17, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, as short-term use, fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214926

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

FDA NDC Directory listings under ANDA 214926
Product	Strength	Form · route	Labeler	Product NDC
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-621
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-622
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-460
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-798
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-945