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NDC 16729-0275-67 Bivalirudin 250 mg/5mL Details
Bivalirudin 250 mg/5mL
Bivalirudin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is BIVALIRUDIN.
Product Information
| NDC | 16729-0275 |
|---|---|
| Product ID | 16729-275_0e1ed629-0701-49af-e063-6394a90a8e2e |
| 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/5mL |
| Substance Name | BIVALIRUDIN |
| Labeler Name | Accord Healthcare, Inc. |
| Pharmaceutical Class | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206551 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 16729-0275-67 (16729027567)
| NDC Package Code | 16729-275-67 |
|---|---|
| Billing NDC | 16729027567 |
| Package | 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) |
| Marketing Start Date | 2018-11-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |