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NDC 42023-0622-01 Bivalirudin 250 mg/1 Details
Bivalirudin 250 mg/1
Bivalirudin is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is BIVALIRUDIN.
Product Information
| NDC | 42023-0622 |
|---|---|
| Product ID | 42023-622_795a02e6-0e33-4b66-8c68-0782006bcf1e |
| Associated GPIs | |
| GCN Sequence Number | 080076 |
| GCN Sequence Number Description | bivalirudin VIAL 250MG/50ML INTRAVEN |
| HIC3 | M9E |
| HIC3 Description | THROMBIN INHIBITORS,SEL,DIRECT,REVERS-HIRUDIN TYPE |
| GCN | 46763 |
| 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, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | BIVALIRUDIN |
| Labeler Name | Par Pharmaceutical, Inc. |
| Pharmaceutical Class | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211215 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42023-0622-01 (42023062201)
| NDC Package Code | 42023-622-01 |
|---|---|
| Billing NDC | 42023062201 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |