standardized mite mix dermatophagoides farinae and dermatophagoides pteronyssinus

Generic: dermatophagoides farinae and dermatophagoides pteronyssinus

Labeler: greer laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name standardized mite mix dermatophagoides farinae and dermatophagoides pteronyssinus
Generic Name dermatophagoides farinae and dermatophagoides pteronyssinus
Labeler greer laboratories, inc.
Dosage Form CONCENTRATE
Routes
INTRADERMAL PERCUTANEOUS SUBCUTANEOUS
Active Ingredients

dermatophagoides farinae 5000 [AU]/mL, dermatophagoides pteronyssinus 5000 [AU]/mL

Manufacturer
Greer Laboratories, Inc.

Identifiers & Regulatory

Product NDC 22840-0037
Product ID 22840-0037_2d7b99ba-afb8-40cd-e063-6294a90a789d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA101834
Listing Expiration 2026-12-31
Marketing Start 2010-02-03

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 228400037
Hyphenated Format 22840-0037

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 mix dermatophagoides farinae and dermatophagoides pteronyssinus (source: ndc)
Generic Name dermatophagoides farinae and dermatophagoides pteronyssinus (source: ndc)
Application Number BLA101834 (source: ndc)
Routes
INTRADERMAL PERCUTANEOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5000 [AU]/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (22840-0037-3)
  • 10 mL in 1 VIAL, MULTI-DOSE (22840-0037-6)
  • 50 mL in 1 VIAL, MULTI-DOSE (22840-0037-9)
source: ndc

Packages (3)

22840-0037-3 5 mL in 1 BOTTLE, DROPPER (22840-0037-3) 22840-0037-6 10 mL in 1 VIAL, MULTI-DOSE (22840-0037-6) 22840-0037-9 50 mL in 1 VIAL, MULTI-DOSE (22840-0037-9)

Ingredients (2)

dermatophagoides farinae (5000 [AU]/mL) 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": "5 mL in 1 BOTTLE, DROPPER (22840-0037-3)", "package_ndc": "22840-0037-3", "marketing_start_date": "20100203"}, {"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (22840-0037-6)", "package_ndc": "22840-0037-6", "marketing_start_date": "20100203"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (22840-0037-9)", "package_ndc": "22840-0037-9", "marketing_start_date": "20100203"}], "brand_name": "Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus", "product_id": "22840-0037_2d7b99ba-afb8-40cd-e063-6294a90a789d", "dosage_form": "CONCENTRATE", "pharm_class": ["Allergens [CS]", "Allergens [CS]", "Antigens", "Dermatophagoides [CS]", "Antigens", "Dermatophagoides [CS]", "Cell-mediated Immunity [PE]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Increased IgG Production [PE]", "Insect Proteins [CS]", "Insect Proteins [CS]", "Standardized Insect Allergenic Extract [EPC]", "Standardized Insect Allergenic Extract [EPC]"], "product_ndc": "22840-0037", "generic_name": "Dermatophagoides farinae and Dermatophagoides pteronyssinus", "labeler_name": "Greer Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus", "active_ingredients": [{"name": "DERMATOPHAGOIDES FARINAE", "strength": "5000 [AU]/mL"}, {"name": "DERMATOPHAGOIDES PTERONYSSINUS", "strength": "5000 [AU]/mL"}], "application_number": "BLA101834", "marketing_category": "BLA", "marketing_start_date": "20100203", "listing_expiration_date": "20261231"}