Standardized Mite Dermatophagoides pteronyssinus is a Intradermal; Percutaneous; Subcutaneous Concentrate in the Human Prescription Drug category. It is labeled and distributed by Greer Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus.
| Product ID | 22840-0039_94191d1d-9858-602a-e053-2a95a90aa50f |
| NDC | 22840-0039 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Standardized Mite Dermatophagoides pteronyssinus |
| Generic Name | Dermatophagoides Pteronyssinus |
| Dosage Form | Concentrate |
| Route of Administration | INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS |
| Marketing Start Date | 2010-02-03 |
| Marketing Category | BLA / BLA |
| Application Number | BLA101835 |
| Labeler Name | Greer Laboratories, Inc. |
| Substance Name | DERMATOPHAGOIDES PTERONYSSINUS |
| Active Ingredient Strength | 30000 [AU]/mL |
| Pharm Classes | Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2010-02-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA101835 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-02-03 |
| Marketing Category | BLA |
| Application Number | BLA101835 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-02-03 |
| Marketing Category | BLA |
| Application Number | BLA101835 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-02-03 |
| Ingredient | Strength |
|---|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 30000 [AU]/mL |
| SPL SET ID: | 9b7f878e-613f-4831-9223-a6a07fb09f1b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 22840-0035 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |
| 22840-0036 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |
| 22840-0039 | Standardized Mite Dermatophagoides pteronyssinus | Dermatophagoides pteronyssinus |
| 36987-1845 | Standardized Mite Dermatophagoides pteronyssinus | Standardized Mite Dermatophagoides pteronyssinus |
| 54575-326 | STANDARDIZED MITE D PTERONYSSINUS | Dermatophagoides pteronyssinus |