House Dust Mite, Dermatophagoides farinae

Product NDC
49643-702
11-digit product format
496430702
Labeler code
49643
Product ID
49643-702_36ad59b6-cc4b-fe11-e063-6394a90ac650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
House Dust Mite, Dermatophagoides farinae
Dosage form
INJECTION
Route
CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Labeler
Allermed Laboratories, Inc.
Application
BLA102212
Marketing category
BLA
Marketing start
1986-12-24
Substance
DERMATOPHAGOIDES FARINAE
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
House Dust Mite, Dermatophagoides farinae
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DERMATOPHAGOIDES FARINAE10000 [AU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPR9U2YPF3Q, 57L1Z5378K
Rxcui852825, 852829

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49643-702-05House Dust Mite, Dermatophagoides farinae5 mL in 1 VIAL, MULTI-DOSEINJECTION55
49643-702-10House Dust Mite, Dermatophagoides farinae10 mL in 1 VIAL, MULTI-DOSEINJECTION105
49643-702-30House Dust Mite, Dermatophagoides farinae30 mL in 1 VIAL, MULTI-DOSEINJECTION305
49643-702-50House Dust Mite, Dermatophagoides farinae50 mL in 1 VIAL, MULTI-DOSEINJECTION505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
PhenolINACTIVE INGREDIENT339NCG44TVHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
Sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RHOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49643-702HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.]4Current NDC, Legacy NDC, 4 package rows20250119_3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSN3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSN3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSY3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSY3b19e1e4-1a28-4515-ac20-cc4a9b2d45e65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49643-702-05496430702055 mL in 1 VIAL, MULTI-DOSE (49643-702-05) 5 ml1986-12-240000-00-00NoNoCurrent
49643-702-104964307021010 mL in 1 VIAL, MULTI-DOSE (49643-702-10) 10 ml1986-12-240000-00-00NoNoCurrent
49643-702-304964307023030 mL in 1 VIAL, MULTI-DOSE (49643-702-30) 30 ml1986-12-240000-00-00NoNoCurrent
49643-702-504964307025050 mL in 1 VIAL, MULTI-DOSE (49643-702-50) 50 ml1986-12-240000-00-00NoNoCurrent