NDC 36987-1844

Standardized Mite Dermatophagoides farinae

Standardized Mite Dermatophagoides Farinae

Standardized Mite Dermatophagoides farinae 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 Farinae.

Product ID36987-1844_c8129b8e-5759-459a-bbc3-02830cadb059
NDC36987-1844
Product TypeHuman Prescription Drug
Proprietary NameStandardized Mite Dermatophagoides farinae
Generic NameStandardized Mite Dermatophagoides Farinae
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1987-06-12
Marketing CategoryBLA / BLA
Application NumberBLA102193
Labeler NameNelco Laboratories, Inc.
Substance NameDERMATOPHAGOIDES FARINAE
Active Ingredient Strength10000 [AU]/mL
Pharm ClassesAllergens [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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1844-2

10 mL in 1 VIAL, MULTI-DOSE (36987-1844-2)
Marketing Start Date1987-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1844-1 [36987184401]

Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-06-12
Inactivation Date2019-10-21

NDC 36987-1844-4 [36987184404]

Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-06-12
Inactivation Date2019-10-21

NDC 36987-1844-3 [36987184403]

Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-06-12
Inactivation Date2019-10-21

NDC 36987-1844-2 [36987184402]

Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-06-12
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE10000 [AU]/mL

OpenFDA Data

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

    • 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 Crossover Matching brand name "Standardized Mite Dermatophagoides farinae" or generic name "Standardized Mite Dermatophagoides Farinae"

    NDCBrand NameGeneric Name
    22840-0033Standardized Mite Dermatophagoides farinaeDermatophagoides farinae
    22840-0034Standardized Mite Dermatophagoides farinaeDermatophagoides farinae
    22840-0038Standardized Mite Dermatophagoides farinaeDermatophagoides farinae
    36987-1844Standardized Mite Dermatophagoides farinaeStandardized Mite Dermatophagoides farinae

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