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
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 |
|---|
| 68083-510-01 | Fomepizole | 1.5 mL in 1 VIAL | INJECTION | 1.5 | | 4 |
| 68083-510-01 | Fomepizole | 1 in 1 CARTON | INJECTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-510 | FOMEPIZOLE INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, 2 package rows | 20230711_7e133194-dacb-446a-a657-2d2430a02373.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 |
|---|
| 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 |