NDC 36987-2065

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 ID36987-2065_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3
NDC36987-2065
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 Strength10000 [PNU]/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 36987-2065-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2065-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2065-3 [36987206503]

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

NDC 36987-2065-2 [36987206502]

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

NDC 36987-2065-1 [36987206501]

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

NDC 36987-2065-4 [36987206504]

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. PULLUTANS10000 [PNU]/mL

OpenFDA Data

SPL SET ID:e464ea5b-a803-4c5a-93d2-cc3fbca8d3a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 999447
  • 967872
  • 967951
  • 999453
  • 999418
  • 967541
  • 999387
  • 889618
  • 307937
  • 999430
  • 999490
  • 867153
  • 999511
  • 999466
  • 968452
  • 968146
  • 1006333
  • 967041
  • 999460
  • 966952
  • 999400
  • 867175
  • 999441
  • 889540
  • 968482
  • 905077
  • 968350
  • 999501
  • 966687
  • 889585
  • 902638
  • 867181
  • 967055
  • 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

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