Fomepizole
- Product NDC
- 70710-1478
- 11-digit product format
- 707101478
- Labeler code
- 70710
- Product ID
- 70710-1478_62ff03a3-fb25-41d8-9c6c-d1ad61ea3d31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fomepizole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA078537
- Marketing category
- ANDA
- Marketing start
- 2021-03-18
- 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 |
|---|
| 70710-1478-1 | Fomepizole | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 70710-1478-1 | Fomepizole | 1.5 mL in 1 VIAL | INJECTION, SOLUTION | 1.5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1478 | FOMEPIZOLE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241222_256910fe-91f2-48f6-b0b4-55edc52dacd4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1478-1 | 70710147801 | 1 VIAL in 1 CARTON (70710-1478-1) / 1.5 mL in 1 VIAL | 1 vial | 2021-03-18 | 0000-00-00 | No | No | Current |