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NDC 64764-0108-21 ENTYVIO Pen 108 mg/.68mL Details
ENTYVIO Pen 108 mg/.68mL
ENTYVIO Pen 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 VEDOLIZUMAB.
MedlinePlus Drug Summary
Vedolizumab injection is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) of the gastrointestinal tract including: Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications. ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) that has not improved when treated with other medications. Vedolizumab injection is in a class of medications called integrin receptor antagonists. It works by blocking the action of certain cells in the body that cause inflammation.
Related Packages: 64764-0108-21Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Vedolizumab Injection
Product Information
| NDC | 64764-0108 |
|---|---|
| Product ID | 64764-108_a01aa894-bc6e-4f36-be45-dd025df6a4d6 |
| Associated GPIs | |
| GCN Sequence Number | 081509 |
| GCN Sequence Number Description | vedolizumab PEN INJCTR 108MG/0.68 SUBCUT |
| HIC3 | D6K |
| HIC3 Description | INTEGRIN RECEPTOR ANTAGONIST, MONOCLONAL ANTIBODY |
| GCN | 48647 |
| HICL Sequence Number | 041146 |
| HICL Sequence Number Description | VEDOLIZUMAB |
| Brand/Generic | Brand |
| Proprietary Name | ENTYVIO Pen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | vedolizumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 108 |
| Active Ingredient Units | mg/.68mL |
| Substance Name | VEDOLIZUMAB |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761133 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64764-0108-21 (64764010821)
| NDC Package Code | 64764-108-21 |
|---|---|
| Billing NDC | 64764010821 |
| Package | 1 TRAY in 1 CARTON (64764-108-21) / 1 SYRINGE in 1 TRAY (64764-108-20) / .68 mL in 1 SYRINGE |
| Marketing Start Date | 2023-09-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |