NDC 0268-7003

Standardized Mite, Mixed

Standardized Mite, Mixed

Standardized Mite, Mixed is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Dermatophagoides Farinae; Dermatophagoides Pteronyssinus.

Product ID0268-7003_0d272bb1-4853-4bef-a694-5aef113225e6
NDC0268-7003
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite, Mixed
Generic NameStandardized Mite, Mixed
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1991-07-08
Marketing CategoryBLA / BLA
Application NumberBLA103060
Labeler NameALK-Abello, Inc.
Substance NameDERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength5000 [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 0268-7003-30

30 mL in 1 VIAL (0268-7003-30)
Marketing Start Date1991-07-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-7003-30 [00268700330]

Standardized Mite, Mixed INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103060
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1991-07-08

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES FARINAE5000 [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]

NDC Crossover Matching brand name "Standardized Mite, Mixed" or generic name "Standardized Mite, Mixed"

NDCBrand NameGeneric Name
0268-7002Standardized Mite, MixedStandardized Mite, Mixed
0268-7003Standardized Mite, MixedStandardized Mite, Mixed
0268-8116STANDARDIZED MITE, MIXEDDERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS

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