house dust mite, dermatophagoides pteronyssinus

Generic: house dust mite, dermatophagoides pteronyssinus

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

Drug Facts

Product Profile

Brand Name house dust mite, dermatophagoides pteronyssinus
Generic Name house dust mite, dermatophagoides pteronyssinus
Labeler allermed laboratories, inc.
Dosage Form INJECTION
Routes
CUTANEOUS INTRADERMAL SUBCUTANEOUS
Active Ingredients

dermatophagoides pteronyssinus 10000 [AU]/mL

Manufacturer
Allermed Laboratories, Inc.

Identifiers & Regulatory

Product NDC 49643-704
Product ID 49643-704_36ad59b6-cc4b-fe11-e063-6394a90ac650
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA102213
Listing Expiration 2026-12-31
Marketing Start 1986-12-24

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 49643704
Hyphenated Format 49643-704

Supplemental Identifiers

RxCUI
852825 852829
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 house dust mite, dermatophagoides pteronyssinus (source: ndc)
Generic Name house dust mite, dermatophagoides pteronyssinus (source: ndc)
Application Number BLA102213 (source: ndc)
Routes
CUTANEOUS INTRADERMAL SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10000 [AU]/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, MULTI-DOSE (49643-704-05)
  • 10 mL in 1 VIAL, MULTI-DOSE (49643-704-10)
  • 30 mL in 1 VIAL, MULTI-DOSE (49643-704-30)
  • 50 mL in 1 VIAL, MULTI-DOSE (49643-704-50)
source: ndc

Packages (4)

Ingredients (1)

dermatophagoides pteronyssinus (10000 [AU]/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["CUTANEOUS", "INTRADERMAL", "SUBCUTANEOUS"], "spl_id": "36ad59b6-cc4b-fe11-e063-6394a90ac650", "openfda": {"nui": ["N0000185005", "N0000175629", "N0000184306", "N0000185001", "M0419493", "M0028968", "M0000728"], "unii": ["57L1Z5378K", "PR9U2YPF3Q"], "rxcui": ["852825", "852829"], "spl_set_id": ["3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6"], "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": ["Allermed Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, MULTI-DOSE (49643-704-05)", "package_ndc": "49643-704-05", "marketing_start_date": "19861224"}, {"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (49643-704-10)", "package_ndc": "49643-704-10", "marketing_start_date": "19861224"}, {"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (49643-704-30)", "package_ndc": "49643-704-30", "marketing_start_date": "19861224"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (49643-704-50)", "package_ndc": "49643-704-50", "marketing_start_date": "19861224"}], "brand_name": "House Dust Mite, Dermatophagoides pteronyssinus", "product_id": "49643-704_36ad59b6-cc4b-fe11-e063-6394a90ac650", "dosage_form": "INJECTION", "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": "49643-704", "generic_name": "House Dust Mite, Dermatophagoides pteronyssinus", "labeler_name": "Allermed Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "House Dust Mite, Dermatophagoides pteronyssinus", "active_ingredients": [{"name": "DERMATOPHAGOIDES PTERONYSSINUS", "strength": "10000 [AU]/mL"}], "application_number": "BLA102213", "marketing_category": "BLA", "marketing_start_date": "19861224", "listing_expiration_date": "20261231"}