Cerebyx (fosphenytoin sodium) NDC 0069-6001

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-6001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-6001Add 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
0069-6001-21	00069600121	10 VIAL in 1 PACKAGE (0069-6001-21) / 10 mL in 1 VIAL (0069-6001-10)Marketed from Oct 28, 2013
0069-6001-25	00069600125	25 VIAL in 1 CARTON (0069-6001-25) / 2 mL in 1 VIAL (0069-6001-02)Marketed from Oct 28, 2013

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): Cerebyx
Generic name (nonproprietary): fosphenytoin sodium
Active ingredients: Fosphenytoin sodium — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020450
Marketing start: Oct 28, 2013
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 0069-6001_c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4SPL ID c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4SPL set ID d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5aRxCUI 1670195, 1670197, 1670200, 1670201UNII 7VLR55452Z
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

N400069600121 followed by a unit qualifier and the quantity

Package 00069-6001-21. 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 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ] . CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, as short-term use, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020450

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

FDA NDC Directory listings under NDA 020450
Product	Strength	Form · route	Labeler	Product NDC
Cerebyxfosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Pfizer Laboratories Div Pfizer Inc	0069-5474
Cerebyxfosphenytoin sodium	Fosphenytoin sodium 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Pfizer Laboratories Div Pfizer Inc	0069-5471