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NDC 70710-1478-01 Fomepizole 1 g/mL Details
Fomepizole 1 g/mL
Fomepizole is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is FOMEPIZOLE.
Product Information
| NDC | 70710-1478 |
|---|---|
| Product ID | 70710-1478_28adc8f9-39f6-44f5-ad0a-e1034885b13e |
| Associated GPIs | 93000045002010 |
| 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, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/mL |
| Substance Name | FOMEPIZOLE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Antidote [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078537 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70710-1478-01 (70710147801)
| NDC Package Code | 70710-1478-1 |
|---|---|
| Billing NDC | 70710147801 |
| Package | 1 VIAL in 1 CARTON (70710-1478-1) / 1.5 mL in 1 VIAL |
| Marketing Start Date | 2021-03-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |