Fomepizole
- Product NDC
- 67457-211
- 11-digit product format
- 674570211
- Labeler code
- 67457
- Product ID
- 67457-211_ac92fef1-664f-4cfd-aa72-b6507934b28f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fomepizole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA078639
- Marketing category
- ANDA
- Marketing start
- 2012-10-09
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fomepizole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOMEPIZOLE | 1 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83LCM6L2BY |
| Rxcui | 310414 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-211-02 | Fomepizole | 1.5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.5 | | 7 |
| 67457-211-02 | Fomepizole | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-211 | FOMEPIZOLE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20210511_911312e2-3a7c-4c97-88a8-b8d92cd12923.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-211-02 | 67457021102 | 1 VIAL, GLASS in 1 CARTON (67457-211-02) / 1.5 mL in 1 VIAL, GLASS | 2012-10-09 | 0000-00-00 | No | No | Current |