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NDC 47783-0101-01 Kalbitor 10 mg/mL Details
Kalbitor 10 mg/mL
Kalbitor is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is ECALLANTIDE.
Product Information
| NDC | 47783-0101 |
|---|---|
| Product ID | 47783-101_18790228-a777-4dc5-a566-aafa7cdeff36 |
| Associated GPIs | 85840030002020 |
| GCN Sequence Number | 065953 |
| GCN Sequence Number Description | ecallantide VIAL 10MG/ML(1) SUBCUT |
| HIC3 | A7N |
| HIC3 Description | PLASMA KALLIKREIN INHIBITORS |
| GCN | 28088 |
| HICL Sequence Number | 036797 |
| HICL Sequence Number Description | ECALLANTIDE |
| Brand/Generic | Brand |
| Proprietary Name | Kalbitor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ecallantide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | ECALLANTIDE |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125277 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47783-0101-01 (47783010101)
| NDC Package Code | 47783-101-01 |
|---|---|
| Billing NDC | 47783010101 |
| Package | 3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2010-02-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |