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NDC 00409-8300-15 Bivalirudin 250 mg/1 Details
Bivalirudin 250 mg/1
Bivalirudin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is BIVALIRUDIN.
Product Information
| NDC | 00409-8300 |
|---|---|
| Product ID | 0409-8300_cf21ebf8-98ae-4e4d-81d7-cd9886b438fa |
| Associated GPIs | 83334020202120 |
| GCN Sequence Number | 047325 |
| GCN Sequence Number Description | bivalirudin VIAL 250 MG INTRAVEN |
| HIC3 | M9E |
| HIC3 Description | THROMBIN INHIBITORS,SEL,DIRECT,REVERS-HIRUDIN TYPE |
| GCN | 12258 |
| HICL Sequence Number | 021872 |
| HICL Sequence Number Description | BIVALIRUDIN |
| Brand/Generic | Generic |
| Proprietary Name | Bivalirudin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BIVALIRUDIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | BIVALIRUDIN |
| Labeler Name | Hospira, Inc. |
| Pharmaceutical Class | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090816 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00409-8300-15 (00409830015)
| NDC Package Code | 0409-8300-15 |
|---|---|
| Billing NDC | 00409830015 |
| Package | 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-8300-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-8300-25) |
| Marketing Start Date | 2015-10-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |