NDC 36987-1845

Standardized Mite Dermatophagoides pteronyssinus

Standardized Mite Dermatophagoides Pteronyssinus

Standardized Mite Dermatophagoides pteronyssinus is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus.

Product ID36987-1845_c8129b8e-5759-459a-bbc3-02830cadb059
NDC36987-1845
Product TypeHuman Prescription Drug
Proprietary NameStandardized Mite Dermatophagoides pteronyssinus
Generic NameStandardized Mite Dermatophagoides Pteronyssinus
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1990-02-22
Marketing CategoryBLA / BLA
Application NumberBLA102194
Labeler NameNelco Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength10000 [AU]/mL
Pharm ClassesStandardized 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1845-3

30 mL in 1 VIAL, MULTI-DOSE (36987-1845-3)
Marketing Start Date1990-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1845-4 [36987184504]

Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1990-02-22
Inactivation Date2019-10-21

NDC 36987-1845-2 [36987184502]

Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1990-02-22
Inactivation Date2019-10-21

NDC 36987-1845-3 [36987184503]

Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1990-02-22
Inactivation Date2019-10-21

NDC 36987-1845-1 [36987184501]

Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1990-02-22
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS10000 [AU]/mL

OpenFDA Data

SPL SET ID:1754a02b-8489-41fa-ae22-5996c0bac5b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 852829
  • 852825
  • Pharmacological Class

    • 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 Crossover Matching brand name "Standardized Mite Dermatophagoides pteronyssinus" or generic name "Standardized Mite Dermatophagoides Pteronyssinus"

    NDCBrand NameGeneric Name
    22840-0035Standardized Mite Dermatophagoides pteronyssinusDermatophagoides pteronyssinus
    22840-0036Standardized Mite Dermatophagoides pteronyssinusDermatophagoides pteronyssinus
    22840-0039Standardized Mite Dermatophagoides pteronyssinusDermatophagoides pteronyssinus
    36987-1845Standardized Mite Dermatophagoides pteronyssinusStandardized Mite Dermatophagoides pteronyssinus

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