Search by Drug Name or NDC
NDC 65219-0429-50 Argatroban 50 mg/50mL Details
Argatroban 50 mg/50mL
Argatroban is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ARGATROBAN.
Product Information
| NDC | 65219-0429 |
|---|---|
| Product ID | 65219-429_f97531bc-3cbb-462f-838a-658caf95ccde |
| Associated GPIs | 83337015002060 |
| GCN Sequence Number | 076985 |
| GCN Sequence Number Description | argatroban in 0.9 % sod chlor VIAL 50 MG/50ML INTRAVEN |
| HIC3 | M9T |
| HIC3 Description | THROMBIN INHIBITORS, SELECTIVE, DIRECT, REVERSIBLE |
| GCN | 42847 |
| HICL Sequence Number | 037600 |
| HICL Sequence Number Description | ARGATROBAN IN 0.9 % SODIUM CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Argatroban |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Argatroban |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/50mL |
| Substance Name | ARGATROBAN |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214235 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0429-50 (65219042950)
| NDC Package Code | 65219-429-50 |
|---|---|
| Billing NDC | 65219042950 |
| Package | 1 VIAL in 1 CARTON (65219-429-50) / 50 mL in 1 VIAL |
| Marketing Start Date | 2021-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |