Home NDC 49643-704-10 House Dust Mite, Dermatophagoides pteronyssinus
Product NDC 49643-704
Requested package NDC 49643-704-10
11-digit product format 496430704
Labeler code 49643
Product ID 49643-704_36ad59b6-cc4b-fe11-e063-6394a90ac650
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name House Dust Mite, Dermatophagoides pteronyssinus
Dosage form INJECTION
Route CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Labeler Allermed Laboratories, Inc.
Application BLA102213
Marketing category BLA
Marketing start 1986-12-24
Substance DERMATOPHAGOIDES PTERONYSSINUS
Active strength 10000 [AU]/mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base House Dust Mite, Dermatophagoides pteronyssinus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PR9U2YPF3Q Internal UNII lookup 57L1Z5378K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 852825 Internal RxNorm lookup 852829 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49643-704-05 House Dust Mite, Dermatophagoides pteronyssinus 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 5 49643-704-10 House Dust Mite, Dermatophagoides pteronyssinus 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 5 49643-704-30 House Dust Mite, Dermatophagoides pteronyssinus 30 mL in 1 VIAL, MULTI-DOSE INJECTION 30 5 49643-704-50 House Dust Mite, Dermatophagoides pteronyssinus 50 mL in 1 VIAL, MULTI-DOSE INJECTION 50 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DERMATOPHAGOIDES FARINAE ACTIVE INGREDIENT PR9U2YPF3Q HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 DERMATOPHAGOIDES PTERONYSSINUS ACTIVE INGREDIENT 57L1Z5378K HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 DERMATOPHAGOIDES FARINAE ACTIVE MOIETY PR9U2YPF3Q HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 DERMATOPHAGOIDES PTERONYSSINUS ACTIVE MOIETY 57L1Z5378K HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 Phenol INACTIVE INGREDIENT 339NCG44TV HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 Sodium bicarbonate INACTIVE INGREDIENT 8MDF5V39QO HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49643-704 HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20250119_3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 102213 Insects (Whole Body), Mite Dermatophagoides pteronyssinus 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49643-704-10 49643070410 10 mL in 1 VIAL, MULTI-DOSE (49643-704-10) 10 ml 1986-12-24 0000-00-00 No No Current