What is NDC 63323-403?

63323-403 is the product NDC for Fosphenytoin (fosphenytoin sodium), Fosphenytoin sodium 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Fosphenytoin (Fosphenytoin sodium).

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fosphenytoin NDC 63323-403 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-403Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0403Add 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
63323-403-02	6332304030263323040302	25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01)Marketed from Dec 14, 2009
63323-403-10	6332304031063323040310	10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)Marketed from Dec 14, 2009

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
Generic name (nonproprietary): fosphenytoin sodium
Active ingredients: Fosphenytoin sodium — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078052
Marketing start: Dec 14, 2009
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 63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3SPL ID 84385df0-4793-47d2-8e49-5c84668a0ba3SPL set ID b60c9c82-e5c7-4e05-98c7-5bbba4af04b2RxCUI 1670195, 1670200UNII 7VLR55452ZUPC 0363323403010, 0363323403041
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

N463323040302 followed by a unit qualifier and the quantity

Package 63323-0403-02. 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 Mar 31, 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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-403

What is NDC 63323-403?: 63323-403 is the product NDC for Fosphenytoin (fosphenytoin sodium), Fosphenytoin sodium 50 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fosphenytoin (Fosphenytoin sodium).
What is the active ingredient?: Fosphenytoin sodium.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Fosphenytoin (Fosphenytoin sodium) NDC 63323-403