FDA.reportPublic FDA data

Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL

Product NDC
65044-6694
11-digit product format
650446694
Labeler code
65044
Product ID
65044-6694_f47bdb36-0d77-467c-9384-d8b4582796a3
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL
Labeler
Jubilant HollisterStier LLC
Application
BLA103871
Marketing category
BLA
Marketing start
1988-05-26
Marketing end
0000-00-00
Substance
DERMATOPHAGOIDES PTERONYSSINUS
Active strength
300 [AU]/mL
Pharmacologic classes
Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65044-6694-5Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL5 mL in 1 VIALINJECTION, SOLUTION518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-6694STANDARDIZED 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 HOLLISTERSTIER16Legacy NDC, 1 package rows20250121_61c5f011-e393-4f9c-b65b-3c06d93baebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192764American house dust mite allergenic extract 15,000 AU/mL / European house dust mite allergenic extract 15,000 AU/mL Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854046American house dust mite extract 30 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854050American house dust mite extract 300 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854052American house dust mite extract 30000 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854071European house dust mite extract 30 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854066European house dust mite extract 300 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
854068European house dust mite extract 30000 AU/ML Injectable SolutionPSN61c5f011-e393-4f9c-b65b-3c06d93baebd18
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192764American house dust mite allergenic extract 15000 AU/ML / European house dust mite allergenic extract 15000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854046American house dust mite allergenic extract 30 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854050American house dust mite allergenic extract 300 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854052American house dust mite allergenic extract 30000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192787American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854071European house dust mite allergenic extract 30 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854066European house dust mite allergenic extract 300 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
854068European house dust mite allergenic extract 30000 AU/ML Injectable SolutionSCD61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192764American house dust mite extract 15,000 AU/ML / European house dust mite extract 15,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192764Dermatophagoides farinae extract 15,000 AU/ML / Dermatophagoides pteronyssinus extract 15,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854046Dermatophagoides farinae extract 30 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854052Dermatophagoides farinae extract 30,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854050Dermatophagoides farinae extract 300 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854071Dermatophagoides pteronyssinus extract 30 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854068Dermatophagoides pteronyssinus extract 30,000 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18
854066Dermatophagoides pteronyssinus extract 300 AU/ML Injectable SolutionSY61c5f011-e393-4f9c-b65b-3c06d93baebd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65044-6694-5650446694055 mL in 1 VIAL5 mlHistorical