NDC 0268-8088

BIPOLARIS SOROKINIANA

Cochliobolus Sativus

BIPOLARIS SOROKINIANA is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Cochliobolus Sativus.

Product ID0268-8088_5fc4dc38-9196-499b-a1ca-b87bc5970555
NDC0268-8088
Product TypeNon-standardized Allergenic
Proprietary NameBIPOLARIS SOROKINIANA
Generic NameCochliobolus Sativus
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameCOCHLIOBOLUS SATIVUS
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0268-8088-10

10.5 mL in 1 VIAL (0268-8088-10)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8088-10 [00268808810]

BIPOLARIS SOROKINIANA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-8088-50 [00268808850]

BIPOLARIS SOROKINIANA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
COCHLIOBOLUS SATIVUS.1 g/mL

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 "Cochliobolus Sativus"

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.