Product NDC: | 50242-040 |
Proprietary Name: | XOLAIR |
Non Proprietary Name: | omalizumab |
Active Ingredient(s): | 202.5 mg/1.4mL & nbsp; omalizumab |
Administration Route(s): | SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50242-040 |
Labeler Name: | Genentech, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA103976 |
Marketing Category: | BLA |
Start Marketing Date: | 20030620 |
Package NDC: | 50242-040-62 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) > 1.4 mL in 1 VIAL, SINGLE-USE |
NDC Code | 50242-040-62 |
Proprietary Name | XOLAIR |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) > 1.4 mL in 1 VIAL, SINGLE-USE |
Product NDC | 50242-040 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | omalizumab |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | SUBCUTANEOUS |
Start Marketing Date | 20030620 |
Marketing Category Name | BLA |
Labeler Name | Genentech, Inc. |
Substance Name | OMALIZUMAB |
Strength Number | 202.5 |
Strength Unit | mg/1.4mL |
Pharmaceutical Classes | Anti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA] |