Fomepizole NDC 68475-510

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0510Add 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
68475-510-01	68475051001	1 VIAL in 1 CARTON (68475-510-01) / 1.5 mL in 1 VIALMarketed from Apr 2, 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): Fomepizole
Generic name (nonproprietary): fomepizole
Active ingredients: Fomepizole — 1 g/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078537
Marketing start: Apr 2, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 68475-510_f8822b9f-00ff-4ad4-a2ed-31bc220528d3SPL ID f8822b9f-00ff-4ad4-a2ed-31bc220528d3SPL set ID 6fed6052-f159-46d6-8be1-31e18a7ba918RxCUI 310414UNII 83LCM6L2BYUPC 0368475510012
Pharmacologic class: Antidote

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

N468475051001 followed by a unit qualifier and the quantity

Package 68475-0510-01. 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 Dec 19, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078537

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

FDA NDC Directory listings under ANDA 078537
Product	Strength	Form · route	Labeler	Product NDC
Fomepizole	Fomepizole 1 g/mL	Injection, SolutionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1478