Home NDC 65044-6691 Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL
Product NDC 65044-6691
11-digit product format 650446691
Labeler code 65044
Product ID 65044-6691_c0f7a73d-257f-46e9-b52d-ec3758576b4b
Type STANDARDIZED ALLERGENIC
Nonproprietary name Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Jubilant HollisterStier LLC
Application BLA103870
Marketing category BLA
Marketing start 1988-05-26
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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL
Listing expiration 2027-12-31 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 65044-6691-2 Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL 10 mL in 1 VIAL INJECTION, SOLUTION 10 18 65044-6691-3 Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL 30 mL in 1 VIAL INJECTION, SOLUTION 30 18 65044-6691-4 Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL 50 mL in 1 VIAL INJECTION, SOLUTION 50 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65044-6691 STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER 16 Current NDC, Legacy NDC, 3 package rows 20250121_61c5f011-e393-4f9c-b65b-3c06d93baebd.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1192764 American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852825 American house dust mite extract 10000 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854046 American house dust mite extract 30 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854050 American house dust mite extract 300 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854052 American house dust mite extract 30000 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192787 Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852829 European house dust mite extract 10000 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854071 European house dust mite extract 30 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854066 European house dust mite extract 300 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854068 European house dust mite extract 30000 AU/ML Injectable Solution PSN 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852825 American house dust mite allergenic extract 10000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192764 American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854046 American house dust mite allergenic extract 30 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854050 American house dust mite allergenic extract 300 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854052 American house dust mite allergenic extract 30000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192787 American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852829 European house dust mite allergenic extract 10000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854071 European house dust mite allergenic extract 30 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854066 European house dust mite allergenic extract 300 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854068 European house dust mite allergenic extract 30000 AU/ML Injectable Solution SCD 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192764 American house dust mite extract 15,000 AU/ML / European house dust mite extract 15,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852825 Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192764 Dermatophagoides farinae extract 15,000 AU/ML / Dermatophagoides pteronyssinus extract 15,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854046 Dermatophagoides farinae extract 30 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854052 Dermatophagoides farinae extract 30,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854050 Dermatophagoides farinae extract 300 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 1192787 Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 852829 Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854071 Dermatophagoides pteronyssinus extract 30 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854068 Dermatophagoides pteronyssinus extract 30,000 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18 854066 Dermatophagoides pteronyssinus extract 300 AU/ML Injectable Solution SY 61c5f011-e393-4f9c-b65b-3c06d93baebd 18
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65044-6691-2 65044669102 10 mL in 1 VIAL (65044-6691-2) 10 ml 1988-05-26 0000-00-00 No No Current 65044-6691-3 65044669103 30 mL in 1 VIAL (65044-6691-3) 30 ml 1988-05-26 0000-00-00 No No Current 65044-6691-4 65044669104 50 mL in 1 VIAL (65044-6691-4) 50 ml 1988-05-26 0000-00-00 No No Current