Fomepizole
- Product NDC
- 68083-510
- 11-digit product format
- 680830510
- Labeler code
- 68083
- Product ID
- 68083-510_69c8a021-8f8d-4989-b5b5-976c1ec5b7b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fomepizole
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216791
- Marketing category
- ANDA
- Marketing start
- 2023-07-06
- Substance
- FOMEPIZOLE
- Active strength
- 1 g/mL
- Pharmacologic classes
- Antidote [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 83LCM6L2BY | FOMEPIZOLE | 7554-65-6 | FOMEPIZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-510-01 | 68083051001 | 1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL | 1 vial | 2023-07-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fomepizole | Gland Pharma Limited | 2023-07-07 | Human Prescription Drug Label | 4 |