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NDC 55150-0210-10 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 Eugia US LLC. The primary component is BIVALIRUDIN.
Product Information
| NDC | 55150-0210 |
|---|---|
| Product ID | 55150-210_5441509c-8a3f-452c-a812-61374fb1423b |
| 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 | Eugia US LLC |
| Pharmaceutical Class | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205962 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0210-10 (55150021010)
| NDC Package Code | 55150-210-10 |
|---|---|
| Billing NDC | 55150021010 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2018-07-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |