NDC 65044-6690

Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL

Standardized Mite Mix, Dermatophagoides Pteronyssinus And Dermatophagoides Farinae, 30000 Au Per Ml

Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Dermatophagoides Farinae; Dermatophagoides Pteronyssinus.

Product ID65044-6690_48ff8f81-67b4-4649-83e6-20002d4a02b8
NDC65044-6690
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL
Generic NameStandardized Mite Mix, Dermatophagoides Pteronyssinus And Dermatophagoides Farinae, 30000 Au Per Ml
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1988-05-26
Marketing CategoryBLA / BLA
Application NumberBLA103870
Labeler NameJubilant HollisterStier LLC
Substance NameDERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength15000 [AU]/mL; [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],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 Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65044-6690-2

10 mL in 1 VIAL (65044-6690-2)
Marketing Start Date1988-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-6690-2 [65044669002]

Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103870
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26

NDC 65044-6690-3 [65044669003]

Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103870
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE15000 [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]
  • 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]

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