NDC 36987-1905

Botrytis cinerea

Botrytis Cinerea

Botrytis cinerea 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 Botrytis Cinerea.

Product ID36987-1905_87be8e36-5ef3-46dc-9497-3254bcf37ec9
NDC36987-1905
Product TypeHuman Prescription Drug
Proprietary NameBotrytis cinerea
Generic NameBotrytis Cinerea
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameBOTRYTIS CINEREA
Active Ingredient Strength20000 [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 36987-1905-1

5 mL in 1 VIAL, MULTI-DOSE (36987-1905-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1905-3 [36987190503]

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

NDC 36987-1905-1 [36987190501]

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

NDC 36987-1905-2 [36987190502]

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

NDC 36987-1905-4 [36987190504]

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

Drug Details

Active Ingredients

IngredientStrength
BOTRYTIS CINEREA20000 [PNU]/mL

OpenFDA Data

SPL SET ID:cd1c8eb7-3b26-4767-b638-b795140a9242
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889579
  • 999456
  • 968484
  • 967953
  • 967904
  • 967543
  • 889538
  • 1000163
  • 999432
  • 999513
  • 999492
  • 968534
  • 999498
  • 968456
  • 968149
  • 999449
  • 966954
  • 999402
  • 999443
  • 999468
  • 999462
  • 1006335
  • 905079
  • 999425
  • 999427
  • 999393
  • 999503
  • 968400
  • 966689
  • 966666
  • 967045
  • 967057
  • 889611
  • 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 "Botrytis cinerea" or generic name "Botrytis Cinerea"

    NDCBrand NameGeneric Name
    0268-0837BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-0838BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-0839BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-0840BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-0841BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-6512BOTRYTIS CINEREABotrytis cinerea
    0268-6513BOTRYTIS CINEREABotrytis cinerea
    0268-8090BOTRYTIS CINEREABOTRYTIS CINEREA
    0268-8091BOTRYTIS CINEREABOTRYTIS CINEREA
    22840-1639Botrytis cinereaBotrytis cinerea
    22840-2662Botrytis cinereaBotrytis cinerea
    22840-5609Botrytis cinereaBotrytis cinerea
    36987-1902Botrytis cinereaBotrytis cinerea
    36987-1903Botrytis cinereaBotrytis cinerea
    36987-1904Botrytis cinereaBotrytis cinerea
    36987-1907Botrytis cinereaBotrytis cinerea
    36987-1909Botrytis cinereaBotrytis cinerea
    36987-1905Botrytis cinereaBotrytis cinerea
    36987-1908Botrytis cinereaBotrytis cinerea
    36987-1906Botrytis cinereaBotrytis cinerea
    36987-1910Botrytis cinereaBotrytis cinerea
    54575-187BOTRYTIS CINEREABOTRYTIS CINEREA

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