Standardized Mite D. farinae

Product NDC
0268-0276
11-digit product format
002680276
Labeler code
0268
Product ID
0268-0276_6ec0580a-501c-4759-818b-9fb7a15611ef
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Mite D. farinae
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103060
Marketing category
BLA
Marketing start
1991-07-08
Marketing end
0000-00-00
Substance
DERMATOPHAGOIDES FARINAE
Active strength
5000 [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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0276-10Standardized Mite D. farinae10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107
0268-0276-30Standardized Mite D. farinae30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISTANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0276STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]7Legacy NDC, 2 package rows20220811_cbe1d24d-df77-4940-baf8-623993fa731b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSNcbe1d24d-df77-4940-baf8-623993fa731b7
852813American house dust mite extract 5000 AU/ML Injectable SolutionPSNcbe1d24d-df77-4940-baf8-623993fa731b7
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSNcbe1d24d-df77-4940-baf8-623993fa731b7
1014384European house dust mite extract 5000 AU/ML Injectable SolutionPSNcbe1d24d-df77-4940-baf8-623993fa731b7
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCDcbe1d24d-df77-4940-baf8-623993fa731b7
852813American house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCDcbe1d24d-df77-4940-baf8-623993fa731b7
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCDcbe1d24d-df77-4940-baf8-623993fa731b7
1014384European house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCDcbe1d24d-df77-4940-baf8-623993fa731b7
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSYcbe1d24d-df77-4940-baf8-623993fa731b7
852813Dermatophagoides farinae extract 5000 AU/ML Injectable SolutionSYcbe1d24d-df77-4940-baf8-623993fa731b7
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSYcbe1d24d-df77-4940-baf8-623993fa731b7
1014384Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable SolutionSYcbe1d24d-df77-4940-baf8-623993fa731b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0276-100026802761010 mL in 1 VIAL, MULTI-DOSE (0268-0276-10) 10 ml1991-07-080000-00-00NoNoCurrent
0268-0276-300026802763030 mL in 1 VIAL, MULTI-DOSE (0268-0276-30) 30 ml1991-07-080000-00-00NoNoCurrent
0268-0276-500026802765050 mL in 1 VIAL, MULTI-DOSE (0268-0276-50) 50 ml1991-07-080000-00-00NoNoCurrent