Fomepizole
- Product NDC
- 25021-829
- 11-digit product format
- 250210829
- Labeler code
- 25021
- Product ID
- 25021-829_2a2d60c6-d777-411f-9ccb-d742fe777dda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fomepizole
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA216791
- Marketing category
- ANDA
- Marketing start
- 2023-11-15
- Substance
- FOMEPIZOLE
- Active strength
- 1.5 g/1.5mL
- 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 | 1.5 g/1.5mL |
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 |
|---|
| 25021-829-02 | Fomepizole | 1.5 mL in 1 VIAL | INJECTION | 1.5 | | 2 |
| 25021-829-02 | Fomepizole | 1 in 1 CARTON | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-829 | FOMEPIZOLE INJECTION [SAGENT PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20231229_1dea37fd-ec17-416e-b28e-980a87d49e1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-829-02 | 25021082902 | 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL | 1 vial | 2023-11-15 | No | No | Historical |