| Product NDC: | 65044-6691 |
| Proprietary Name: | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
| Non Proprietary Name: | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
| Active Ingredient(s): | 5000; 5000 [AU]/mL; [AU]/mL & nbsp; Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65044-6691 |
| Labeler Name: | Jubilant HollisterStier LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA103870 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19880526 |
| Package NDC: | 65044-6691-2 |
| Package Description: | 10 mL in 1 VIAL (65044-6691-2) |
| NDC Code | 65044-6691-2 |
| Proprietary Name | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
| Package Description | 10 mL in 1 VIAL (65044-6691-2) |
| Product NDC | 65044-6691 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 19880526 |
| Marketing Category Name | BLA |
| Labeler Name | Jubilant HollisterStier LLC |
| Substance Name | DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS |
| Strength Number | 5000; 5000 |
| Strength Unit | [AU]/mL; [AU]/mL |
| Pharmaceutical Classes | Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Protein Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] |