standardized mite dermatophagoides pteronyssinus (22840-0035)

Drug Facts

Product Profile

Brand Name standardized mite dermatophagoides pteronyssinus

Generic Name dermatophagoides pteronyssinus

Labeler greer laboratories, inc.

Dosage Form CONCENTRATE

Routes

INTRADERMAL PERCUTANEOUS SUBCUTANEOUS

Active Ingredients

dermatophagoides pteronyssinus 5000 [AU]/mL

Manufacturer

Greer Laboratories, Inc.

Identifiers & Regulatory

Product NDC 22840-0035

Product ID 22840-0035_2d7b99ba-afb8-40cd-e063-6294a90a789d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category BLA

Application Number BLA101835

Listing Expiration 2026-12-31

Marketing Start 1989-06-27

Pharmacologic Class

Established (EPC)

standardized insect allergenic extract [epc]

Chemical Structure

antigens, dermatophagoides [cs] insect proteins [cs] allergens [cs]

Physiologic Effect

increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 228400035

Hyphenated Format 22840-0035

Supplemental Identifiers

RxCUI

852813 852825 852829 854052 854068 1014384 1192787

UNII

57L1Z5378K PR9U2YPF3Q

NUI

N0000185005 N0000175629 N0000184306 N0000185001 M0419493 M0028968 M0000728

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name standardized mite dermatophagoides pteronyssinus (source: ndc)

Generic Name dermatophagoides pteronyssinus (source: ndc)

Application Number BLA101835 (source: ndc)

Routes

INTRADERMAL PERCUTANEOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

5000 [AU]/mL

source: ndc

Packaging

10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6)
50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9)

source: ndc

Packages (2)

22840-0035-6 10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6) 22840-0035-9 50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9)

Ingredients (1)

dermatophagoides pteronyssinus (5000 [AU]/mL)

Linked Drug Pages (1)

Standardized Mite Dermatophagoides farinae, Standardized Mite Dermatophagoides pteronyssinus, Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRADERMAL", "PERCUTANEOUS", "SUBCUTANEOUS"], "spl_id": "2d7b99ba-afb8-40cd-e063-6294a90a789d", "openfda": {"nui": ["N0000185005", "N0000175629", "N0000184306", "N0000185001", "M0419493", "M0028968", "M0000728"], "unii": ["57L1Z5378K", "PR9U2YPF3Q"], "rxcui": ["852813", "852825", "852829", "854052", "854068", "1014384", "1192787"], "spl_set_id": ["9b7f878e-613f-4831-9223-a6a07fb09f1b"], "pharm_class_cs": ["Antigens, Dermatophagoides [CS]", "Insect Proteins [CS]", "Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Standardized Insect Allergenic Extract [EPC]"], "manufacturer_name": ["Greer Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6)", "package_ndc": "22840-0035-6", "marketing_start_date": "19890627"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9)", "package_ndc": "22840-0035-9", "marketing_start_date": "19890627"}], "brand_name": "Standardized Mite Dermatophagoides pteronyssinus", "product_id": "22840-0035_2d7b99ba-afb8-40cd-e063-6294a90a789d", "dosage_form": "CONCENTRATE", "pharm_class": ["Allergens [CS]", "Antigens", "Dermatophagoides [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Insect Proteins [CS]", "Standardized Insect Allergenic Extract [EPC]"], "product_ndc": "22840-0035", "generic_name": "Dermatophagoides pteronyssinus", "labeler_name": "Greer Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Standardized Mite Dermatophagoides pteronyssinus", "active_ingredients": [{"name": "DERMATOPHAGOIDES PTERONYSSINUS", "strength": "5000 [AU]/mL"}], "application_number": "BLA101835", "marketing_category": "BLA", "marketing_start_date": "19890627", "listing_expiration_date": "20261231"}