NDC 65044-6692

Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL

Standardized Mite, Dermatophagoides Pteronyssinus, Scratch Or Bulk, 30000 Au Per Ml

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

Product ID65044-6692_48ff8f81-67b4-4649-83e6-20002d4a02b8
NDC65044-6692
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL
Generic NameStandardized Mite, Dermatophagoides Pteronyssinus, Scratch Or Bulk, 30000 Au Per Ml
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1988-05-26
Marketing CategoryBLA / BLA
Application NumberBLA103871
Labeler NameJubilant HollisterStier LLC
Substance NameDERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength30000 [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 FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65044-6692-1

5 mL in 1 VIAL (65044-6692-1)
Marketing Start Date1988-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-6692-3 [65044669203]

Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103871
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26

NDC 65044-6692-2 [65044669202]

Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103871
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26

NDC 65044-6692-1 [65044669201]

Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103871
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS30000 [AU]/mL

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]

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