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NDC 25021-0829-02 Fomepizole 1.5 g/1.5mL Details
Fomepizole 1.5 g/1.5mL
Fomepizole is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is FOMEPIZOLE.
Product Information
| NDC | 25021-0829 |
|---|---|
| Product ID | 25021-829_2a2d60c6-d777-411f-9ccb-d742fe777dda |
| Associated GPIs | |
| GCN Sequence Number | 037000 |
| GCN Sequence Number Description | fomepizole VIAL 1 G/ML INTRAVEN |
| HIC3 | C8E |
| HIC3 Description | ANTIDOTES,MISCELLANEOUS |
| GCN | 07565 |
| HICL Sequence Number | 016908 |
| HICL Sequence Number Description | FOMEPIZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Fomepizole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fomepizole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1.5 |
| Active Ingredient Units | g/1.5mL |
| Substance Name | FOMEPIZOLE |
| Labeler Name | Sagent Pharmaceuticals |
| Pharmaceutical Class | Antidote [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216791 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 25021-0829-02 (25021082902)
| NDC Package Code | 25021-829-02 |
|---|---|
| Billing NDC | 25021082902 |
| Package | 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL |
| Marketing Start Date | 2023-11-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |