NDC 36987-2071

Aureobasidium pullulans

Aureobasidium Pullulans

Aureobasidium pullulans is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Aureobasidium Pullulans Var. Pullutans.

Product ID36987-2071_9ea18f57-b968-4c63-84f4-9e6ae475d10f
NDC36987-2071
Product TypeHuman Prescription Drug
Proprietary NameAureobasidium pullulans
Generic NameAureobasidium Pullulans
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameAUREOBASIDIUM PULLULANS VAR. PULLUTANS
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2071-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2071-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2071-4 [36987207104]

Aureobasidium pullulans INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-2071-3 [36987207103]

Aureobasidium pullulans INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-2071-1 [36987207101]

Aureobasidium pullulans INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-2071-2 [36987207102]

Aureobasidium pullulans INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS.1 g/mL

OpenFDA Data

SPL SET ID:3484572a-db45-479f-8ba4-39a9d1b00d04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854133
  • 892677
  • 852469
  • 1006326
  • 852105
  • 968480
  • 852401
  • 1012148
  • 1011991
  • 852375
  • 968143
  • 1010906
  • 967949
  • 967869
  • 901848
  • 889542
  • 852763
  • 968210
  • 1006290
  • 967534
  • 905075
  • 1012033
  • 852192
  • 968448
  • 966685
  • 889587
  • 889620
  • 995697
  • 1012102
  • 852060
  • 967053
  • 967032
  • 1012043
  • Pharm Class PE
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
  • PHarm Class EPC
  • Non-Standardized Fungal Allergenic Extract [EPC]
  • NUI Code
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306
  • Pharmacological Class

    • Non-Standardized Fungal Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Fungal Proteins [CS]
    • Allergens [CS]

    NDC Crossover Matching brand name "Aureobasidium pullulans" or generic name "Aureobasidium Pullulans"

    NDCBrand NameGeneric Name
    0268-8086AUREOBASIDIUM PULLULANSAUREOBASIDIUM PULLULANS VAR. PULLUTANS
    0268-8087AUREOBASIDIUM PULLULANSAUREOBASIDIUM PULLULANS VAR. PULLUTANS
    22840-1630Aureobasidium pullulansAureobasidium pullulans
    22840-5607Aureobasidium pullulansAureobasidium pullulans
    36987-2064Aureobasidium pullulansAureobasidium pullulans
    36987-2065Aureobasidium pullulansAureobasidium pullulans
    36987-2066Aureobasidium pullulansAureobasidium pullulans
    36987-2067Aureobasidium pullulansAureobasidium pullulans
    36987-2068Aureobasidium pullulansAureobasidium pullulans
    36987-2069Aureobasidium pullulansAureobasidium pullulans
    36987-2070Aureobasidium pullulansAureobasidium pullulans
    36987-2071Aureobasidium pullulansAureobasidium pullulans
    36987-2072Aureobasidium pullulansAureobasidium pullulans

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