Standardized Mite D. pteronyssinus

Product NDC
0268-7001
11-digit product format
002687001
Labeler code
0268
Product ID
0268-7001_7641d225-ff95-44d4-9279-296d84b96b05
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Mite D. pteronyssinus
Dosage form
SOLUTION
Route
PERCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103752
Marketing category
BLA
Marketing start
1990-08-14
Substance
DERMATOPHAGOIDES PTERONYSSINUS
Active strength
10000 [AU]/mL
Pharmacologic classes
Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Standardized Mite D. pteronyssinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS10000 [AU]/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-7001-06Standardized Mite D. pteronyssinus5 mL in 1 VIAL, MULTI-DOSESOLUTION57

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
0268-7001STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.]7Current NDC, Legacy NDC, 1 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
0268-7001-06002687001065 mL in 1 VIAL, MULTI-DOSE (0268-7001-06) 5 ml1990-08-140000-00-00NoNoCurrent