Prescription drug · ANDA
fomepizole NDC 0517-0710
Fomepizole 1 g/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| 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.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078368
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N400517071088followed by a unit qualifier and the quantityPackage 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 .
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.