Home NDC 0268-8116 STANDARDIZED MITE, MIXED
Product NDC 0268-8116
11-digit product format 002688116
Labeler code 0268
Product ID 0268-8116_0922c304-5b4a-4bb6-a9f2-a3603ec2e7ba
Type STANDARDIZED ALLERGENIC
Nonproprietary name DERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS
Dosage form INJECTION, SOLUTION
Route PERCUTANEOUS
Labeler ALK-Abello, Inc.
Application BLA103060
Marketing category BLA
Marketing start 1991-07-08
Substance DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
Active strength 5000; 5000 [AU]/mL; [AU]/mL
Pharmacologic classes 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]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0268-8116 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0268-8116 0268-8116-06 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base STANDARDIZED MITE, MIXED
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DERMATOPHAGOIDES FARINAE 5000 [AU]/mL DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-8116-06 STANDARDIZED MITE, MIXED 5.5 mL in 1 VIAL INJECTION, SOLUTION 5.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-8116 STANDARDIZED MITE, MIXED (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALK-ABELLO, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20200205_56f6254a-1406-4dbd-87ce-5b97dcebd03b.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103060 Insects (Whole Body), Mite Dermatophagoides farinae 351(a) Rx 2026-08-01
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 0268-8116-06 00268811606 5.5 mL in 1 VIAL (0268-8116-06) 5.5 ml 1991-07-08 0000-00-00 No No Current