STANDARDIZED MITE D FARINAE

Product NDC
54575-325
11-digit product format
545750325
Labeler code
54575
Product ID
54575-325_27179a6a-453e-4e7d-8115-f98dcfcf3ec5
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Dermatophagoides farinae
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Allergy Laboratories, Inc.
Application
BLA101377
Marketing category
BLA
Marketing start
1989-01-25
Marketing end
0000-00-00
Substance
DERMATOPHAGOIDES FARINAE
Active strength
10000 [AU]/mL
Pharmacologic classes
Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54575-325-02STANDARDIZED MITE D FARINAE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION27
54575-325-10STANDARDIZED MITE D FARINAE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107
54575-325-30STANDARDIZED MITE D FARINAE30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION307
54575-325-50STANDARDIZED MITE D FARINAE50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION507

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RSTANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54575-325STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]7Legacy NDC, 4 package rows20170807_073f4c55-7bc3-4dd1-ae93-74f500cd912e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSN073f4c55-7bc3-4dd1-ae93-74f500cd912e7
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSN073f4c55-7bc3-4dd1-ae93-74f500cd912e7
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD073f4c55-7bc3-4dd1-ae93-74f500cd912e7
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD073f4c55-7bc3-4dd1-ae93-74f500cd912e7
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSY073f4c55-7bc3-4dd1-ae93-74f500cd912e7
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSY073f4c55-7bc3-4dd1-ae93-74f500cd912e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54575-325-02545750325022 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
54575-325-105457503251010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
54575-325-305457503253030 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
54575-325-505457503255050 mL in 1 VIAL, MULTI-DOSE50 mlHistorical