Prescription drug · ANDA
Fomepizole NDC 25021-829
Fomepizole 1.5 g/1.5mL · Injection · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-829-02 | 25021082902 | 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIALMarketed from Nov 15, 2023 |
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 — 1.5 g/1.5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216791
- Marketing start
- Listing expires
- Identifiers
- Product ID 25021-829_2a2d60c6-d777-411f-9ccb-d742fe777ddaSPL ID 2a2d60c6-d777-411f-9ccb-d742fe777ddaSPL set ID 1dea37fd-ec17-416e-b28e-980a87d49e1aRxCUI 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
N425021082902followed by a unit qualifier and the quantityPackage 25021-0829-02. 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 .
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.
Other NDCs under ANDA 216791
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fomepizole | Fomepizole 1 g/mL | InjectionIntravenous | Gland Pharma Limited | 68083-510 |