NDC 65044-6694

Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL

Standardized Mite, Dermatophagoides Pteronyssinus, Intradermal, 300 Au Per Ml

Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL is a Intradermal Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Dermatophagoides Pteronyssinus.

Product ID65044-6694_f47bdb36-0d77-467c-9384-d8b4582796a3
NDC65044-6694
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL
Generic NameStandardized Mite, Dermatophagoides Pteronyssinus, Intradermal, 300 Au Per Ml
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1988-05-26
Marketing CategoryBLA / BLA
Application NumberBLA103871
Labeler NameJubilant HollisterStier LLC
Substance NameDERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength300 [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 Through2019-12-31

Packaging

NDC 65044-6694-5

5 mL in 1 VIAL (65044-6694-5)
Marketing Start Date1988-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-6694-5 [65044669405]

Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103871
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26
Marketing End Date2017-02-02

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS300 [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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