NDC 36987-1992

Bipolaris sorokiniana

Bipolaris Sorokiniana

Bipolaris sorokiniana 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 Cochliobolus Sativus.

Product ID36987-1992_42de87a6-4ad2-4dd1-ae19-915aec27f42c
NDC36987-1992
Product TypeHuman Prescription Drug
Proprietary NameBipolaris sorokiniana
Generic NameBipolaris Sorokiniana
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameCOCHLIOBOLUS SATIVUS
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 36987-1992-4

50 mL in 1 VIAL, MULTI-DOSE (36987-1992-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1992-4 [36987199204]

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

NDC 36987-1992-1 [36987199201]

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

NDC 36987-1992-3 [36987199203]

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

NDC 36987-1992-2 [36987199202]

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

Drug Details

Active Ingredients

IngredientStrength
COCHLIOBOLUS SATIVUS10000 [PNU]/mL

OpenFDA Data

SPL SET ID:182f7346-1f19-44b1-bc8f-d7c543a1c4dc
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 "Bipolaris sorokiniana" or generic name "Bipolaris Sorokiniana"

    NDCBrand NameGeneric Name
    0268-8088BIPOLARIS SOROKINIANACOCHLIOBOLUS SATIVUS
    0268-8089BIPOLARIS SOROKINIANACOCHLIOBOLUS SATIVUS
    22840-1632Bipolaris sorokinianaBipolaris sorokiniana
    22840-1633Bipolaris sorokinianaBipolaris sorokiniana
    22840-1634Bipolaris sorokinianaBipolaris sorokiniana
    22840-1635Bipolaris sorokinianaBipolaris sorokiniana
    22840-1636Bipolaris sorokinianaBipolaris sorokiniana
    22840-2661Bipolaris sorokinianaBipolaris sorokiniana
    22840-5608Bipolaris sorokinianaBipolaris sorokiniana
    36987-1992Bipolaris sorokinianaBipolaris sorokiniana
    36987-1993Bipolaris sorokinianaBipolaris sorokiniana
    36987-1997Bipolaris sorokinianaBipolaris sorokiniana
    36987-1995Bipolaris sorokinianaBipolaris sorokiniana
    36987-2000Bipolaris sorokinianaBipolaris sorokiniana
    36987-1999Bipolaris sorokinianaBipolaris sorokiniana
    36987-1994Bipolaris sorokinianaBipolaris sorokiniana
    36987-1998Bipolaris sorokinianaBipolaris sorokiniana
    36987-1996Bipolaris sorokinianaBipolaris sorokiniana

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