What is NDC 68083-461?

68083-461 is the product NDC for Fosphenytoin sodium, Fosphenytoin sodium 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fosphenytoin sodium?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fosphenytoin sodium NDC 68083-461 | National Drug Code

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	6808304611068083046110	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 LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214926
Marketing start: Oct 13, 2023
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 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)

About NDC 68083-461

What is NDC 68083-461?: 68083-461 is the product NDC for Fosphenytoin sodium, Fosphenytoin sodium 50 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fosphenytoin sodium.
What is the active ingredient?: Fosphenytoin sodium.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fosphenytoin sodium?: 11 other product NDCs are listed under this name. See all Fosphenytoin 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 Fosphenytoin sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-945	68462-0945-64
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-798	25021-0798-0225021-0798-10
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-460	68083-0460-25
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-621	68462-0621-54
Fosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-622	68462-0622-64
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Amneal Pharmaceuticals LLC	65162-998	65162-0998-25
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Amneal Pharmaceuticals LLC	65162-999	65162-0999-10
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	West-Ward Pharmaceuticals Corp	0143-9782	00143-9782-10
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	West-Ward Pharmaceuticals Corp	0143-9788	00143-9788-25
Fosphenytoin Sodium	Fosphenytoin sodium 50 mg/mL	InjectionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6136	00641-6136-25

All 12 Fosphenytoin sodium NDCs

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	Sagent Pharmaceuticals	25021-798
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	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	GLENMARK PHARMACEUTICALS INC., USA	68462-945