NDC 49288-0174

Standardized Mite, Dermatophagoides pteronyssinus

Standardized Mite, Dermatophagoides Pteronyssinus

Standardized Mite, Dermatophagoides pteronyssinus is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus.

Product ID49288-0174_745162a9-2fdc-4b03-a3bc-32d410b3d9c1
NDC49288-0174
Product TypeHuman Prescription Drug
Proprietary NameStandardized Mite, Dermatophagoides pteronyssinus
Generic NameStandardized Mite, Dermatophagoides Pteronyssinus
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1991-10-22
Marketing CategoryBLA / BLA
Application NumberBLA102225
Labeler NameAntigen Laboratories, Inc.
Substance NameDERMATOPHAGOIDES PTERONYSSINUS
Active Ingredient Strength5000 [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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0174-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0174-3)
Marketing Start Date1991-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0174-3 [49288017403]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1991-10-22
Inactivation Date2019-10-21

NDC 49288-0174-5 [49288017405]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1991-10-22
Inactivation Date2019-10-21

NDC 49288-0174-4 [49288017404]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1991-10-22
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
DERMATOPHAGOIDES PTERONYSSINUS5000 [AU]/mL

OpenFDA Data

SPL SET ID:3b3cb12c-65d3-46ab-9bac-82c569a76220
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 852813
  • 1192787
  • 1014382
  • 1014384
  • 852825
  • 1014369
  • 852829
  • 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, Dermatophagoides pteronyssinus" or generic name "Standardized Mite, Dermatophagoides Pteronyssinus"

    NDCBrand NameGeneric Name
    49288-0172Standardized Mite, Dermatophagoides pteronyssinusStandardized Mite, Dermatophagoides pteronyssinus
    49288-0173Standardized Mite, Dermatophagoides pteronyssinusStandardized Mite, Dermatophagoides pteronyssinus
    49288-0174Standardized Mite, Dermatophagoides pteronyssinusStandardized Mite, Dermatophagoides pteronyssinus

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