NDC 65044-6721

Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL

Standardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml

Standardized Mite, Dermatophagoides farinae, Intradermal, 30 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 Farinae.

Product ID65044-6721_f47bdb36-0d77-467c-9384-d8b4582796a3
NDC65044-6721
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL
Generic NameStandardized Mite, Dermatophagoides Farinae, Intradermal, 30 Au Per Ml
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1988-05-26
Marketing CategoryBLA / BLA
Application NumberBLA103870
Labeler NameJubilant HollisterStier LLC
Substance NameDERMATOPHAGOIDES FARINAE
Active Ingredient Strength30 [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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-6721-5

5 mL in 1 VIAL (65044-6721-5)
Marketing Start Date1988-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-6721-5 [65044672105]

Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103870
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1988-05-26
Marketing End Date2016-12-15

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE30 [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]

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.