FDA.reportPublic FDA data

Standardized Mite, Mixed

Product NDC
0268-7003
11-digit product format
002687003
Labeler code
0268
Product ID
0268-7003_0d272bb1-4853-4bef-a694-5aef113225e6
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Mite, Mixed
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; DERMATOPHAGOIDES PTERONYSSINUS
Active strength
5000 [AU]/mL; [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],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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0268-7003DDiscontinued by firm2026-09-09
excluded packagepackage0268-70030268-7003-30DDiscontinued by firm2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0268-7003-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0268-7003-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
0268-7003-30Standardized Mite, Mixed30 mL in 1 VIALINJECTION, SOLUTION306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
PHENOLINACTIVE INGREDIENT339NCG44TVSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISTANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-7003STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.]5Legacy NDC, 1 package rows20200221_4a3539da-7f51-401b-8ac2-101b8a4658f4.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103060Insects (Whole Body), Mite Dermatophagoides farinae351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionPSN4a3539da-7f51-401b-8ac2-101b8a4658f46
1192787American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCD4a3539da-7f51-401b-8ac2-101b8a4658f46
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionSY4a3539da-7f51-401b-8ac2-101b8a4658f46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-7003-300026870033030 mL in 1 VIAL (0268-7003-30) 30 ml1991-07-080000-00-00NoNoCurrent