What is NDC 0517-0710?

0517-0710 is the product NDC for fomepizole, Fomepizole 1 g/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for fomepizole?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

fomepizole NDC 0517-0710 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-0710Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-0710Add 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
0517-0710-88	00517071088	1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIALMarketed from Jul 31, 2020

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): fomepizole
Generic name (nonproprietary): fomepizole
Active ingredients: Fomepizole — 1 g/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078368
Marketing start: Jul 31, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 0517-0710_aac796de-58f6-49e5-b959-f95b0c7b8889SPL ID aac796de-58f6-49e5-b959-f95b0c7b8889SPL set ID a31d0148-2729-49de-b666-f24b0dfd2401RxCUI 310414UNII 83LCM6L2BY
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

N400517071088 followed by a unit qualifier and the quantity

Package 00517-0710-88. 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 Feb 11, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fomepizole injection 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)

About NDC 0517-0710

What is NDC 0517-0710?: 0517-0710 is the product NDC for fomepizole, Fomepizole 1 g/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: fomepizole.
What is the active ingredient?: Fomepizole.
Who is the labeler?: American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for fomepizole?: 5 other product NDCs are listed under this name. See all fomepizole 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 fomepizole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fomepizole	Fomepizole 1.5 g/1.5mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-829	25021-0829-02
Fomepizole	Fomepizole 1 g/mL	InjectionIntravenous	Gland Pharma Limited	68083-510	68083-0510-01
Fomepizole	Fomepizole 1 g/mL	Injection, SolutionIntravenous	Navinta LLC	68475-510	68475-0510-01
Fomepizole	Fomepizole 1 g/mL	Injection, SolutionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-1478	70710-1478-01
Fomepizole	Fomepizole 1 g/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	67457-211	67457-0211-02