NDC 0268-0277

Standardized Mite D. pteronyssinus

Standardized Mite D. Pteronyssinus

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

Product ID0268-0277_64709142-a40b-4ce8-8bb9-02459e658b05
NDC0268-0277
Product TypeStandardized Allergenic
Proprietary NameStandardized Mite D. pteronyssinus
Generic NameStandardized Mite D. Pteronyssinus
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1990-08-14
Marketing CategoryBLA / BLA
Application NumberBLA103752
Labeler NameALK-Abello, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength10000 [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 0268-0277-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0277-10)
Marketing Start Date1990-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0277-10 [00268027710]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103752
Product TypeSTANDARDIZED ALLERGENIC
Billing UnitML
Marketing Start Date1990-08-14

NDC 0268-0277-50 [00268027750]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103752
Product TypeSTANDARDIZED ALLERGENIC
Billing UnitML
Marketing Start Date1990-08-14

NDC 0268-0277-30 [00268027730]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103752
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1990-08-14

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS10000 [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]

NDC Crossover Matching brand name "Standardized Mite D. pteronyssinus" or generic name "Standardized Mite D. Pteronyssinus"

NDCBrand NameGeneric Name
0268-0277Standardized Mite D. pteronyssinusStandardized Mite D. pteronyssinus
0268-0278Standardized Mite D. pteronyssinusStandardized Mite D. pteronyssinus
0268-7001Standardized Mite D. pteronyssinusStandardized Mite D. pteronyssinus

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