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NDC 47783-0646-01 TAKHZYRO 300 mg/2mL Details
TAKHZYRO 300 mg/2mL
TAKHZYRO is a SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is LANADELUMAB.
MedlinePlus Drug Summary
Lanadelumab-flyo injection is used to prevent swelling and painful attacks of hereditary angioedema (HAE; an inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines) in adults and children 12 years of age or older. Lanadelumab-flyo is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes swelling and pain associated with HAE.
Related Packages: 47783-0646-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lanadelumab-flyo injection
Product Information
| NDC | 47783-0646 |
|---|---|
| Product ID | 47783-646_7b67bee7-cd75-431e-949e-39399e849426 |
| Associated GPIs | 8584204020E520 |
| GCN Sequence Number | 081825 |
| GCN Sequence Number Description | lanadelumab-flyo SYRINGE 300 MG/2ML SUBCUT |
| HIC3 | A7N |
| HIC3 Description | PLASMA KALLIKREIN INHIBITORS |
| GCN | 49055 |
| HICL Sequence Number | 045177 |
| HICL Sequence Number Description | LANADELUMAB-FLYO |
| Brand/Generic | Brand |
| Proprietary Name | TAKHZYRO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lanadelumab-flyo |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/2mL |
| Substance Name | LANADELUMAB |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761090 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47783-0646-01 (47783064601)
| NDC Package Code | 47783-646-01 |
|---|---|
| Billing NDC | 47783064601 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2022-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |