Standardized Mite Dermatophagoides farinae

Product NDC
36987-1844
11-digit product format
369871844
Labeler code
36987
Product ID
36987-1844_c8129b8e-5759-459a-bbc3-02830cadb059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Standardized Mite Dermatophagoides farinae
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Nelco Laboratories, Inc.
Application
BLA102193
Marketing category
BLA
Marketing start
1987-06-12
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
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36987-1844-1Standardized Mite Dermatophagoides farinae5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
36987-1844-2Standardized Mite Dermatophagoides farinae10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
36987-1844-3Standardized Mite Dermatophagoides farinae30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION301
36987-1844-4Standardized Mite Dermatophagoides farinae50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51STANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74STANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSTANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36987-1844STANDARDIZED MITE DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION [NELCO LABORATORIES, INC.]1Legacy NDC, 4 package rows20091217_1754a02b-8489-41fa-ae22-5996c0bac5b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSN1754a02b-8489-41fa-ae22-5996c0bac5b31
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSN1754a02b-8489-41fa-ae22-5996c0bac5b31
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD1754a02b-8489-41fa-ae22-5996c0bac5b31
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD1754a02b-8489-41fa-ae22-5996c0bac5b31
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSY1754a02b-8489-41fa-ae22-5996c0bac5b31
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSY1754a02b-8489-41fa-ae22-5996c0bac5b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36987-1844-1369871844015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
36987-1844-23698718440210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
36987-1844-33698718440330 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
36987-1844-43698718440450 mL in 1 VIAL, MULTI-DOSE50 mlHistorical