NDC 54575-325

STANDARDIZED MITE D FARINAE

Dermatophagoides Farinae

STANDARDIZED MITE D FARINAE is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Dermatophagoides Farinae.

Product ID54575-325_27179a6a-453e-4e7d-8115-f98dcfcf3ec5
NDC54575-325
Product TypeStandardized Allergenic
Proprietary NameSTANDARDIZED MITE D FARINAE
Generic NameDermatophagoides Farinae
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1989-01-25
Marketing CategoryBLA / BLA
Application NumberBLA101377
Labeler NameAllergy 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 Through2018-12-31

Packaging

NDC 54575-325-02

2 mL in 1 VIAL, MULTI-DOSE (54575-325-02)
Marketing Start Date1989-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54575-325-30 [54575032530]

STANDARDIZED MITE D FARINAE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101377
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1989-01-25
Inactivation Date2020-01-31

NDC 54575-325-50 [54575032550]

STANDARDIZED MITE D FARINAE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101377
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1989-01-25
Inactivation Date2020-01-31

NDC 54575-325-02 [54575032502]

STANDARDIZED MITE D FARINAE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101377
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1989-01-25
Inactivation Date2020-01-31

NDC 54575-325-10 [54575032510]

STANDARDIZED MITE D FARINAE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101377
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1989-01-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE10000 [AU]/mL

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 D FARINAE" or generic name "Dermatophagoides Farinae"

NDCBrand NameGeneric Name
54575-325STANDARDIZED MITE D FARINAEDermatophagoides farinae
22840-0033Standardized Mite Dermatophagoides farinaeDermatophagoides farinae
22840-0034Standardized Mite Dermatophagoides farinaeDermatophagoides farinae
22840-0038Standardized Mite Dermatophagoides farinaeDermatophagoides farinae

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