NDC 0268-0882

COCHLIOBOLUS SATIVUS

Helminthosporium Sorokinianum

COCHLIOBOLUS SATIVUS 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 ID0268-0882_152accc2-8563-4b11-9c7c-f61b002b30f8
NDC0268-0882
Product TypeNon-standardized Allergenic
Proprietary NameCOCHLIOBOLUS SATIVUS
Generic NameHelminthosporium Sorokinianum
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 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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0268-0882-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0882-10)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0882-10 [00268088210]

COCHLIOBOLUS SATIVUS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-0882-50 [00268088250]

COCHLIOBOLUS SATIVUS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
COCHLIOBOLUS SATIVUS20000 [PNU]/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 "COCHLIOBOLUS SATIVUS" or generic name "Helminthosporium Sorokinianum"

NDCBrand NameGeneric Name
0268-0878COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-0879COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-0880COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-0881COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-0882COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-0883COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-6524COCHLIOBOLUS SATIVUSHELMINTHOSPORIUM SOROKINIANUM
0268-6525COCHLIOBOLUS SATIVUSDrechslera Helminthosporium
0268-8088BIPOLARIS SOROKINIANACOCHLIOBOLUS SATIVUS
0268-8089BIPOLARIS SOROKINIANACOCHLIOBOLUS SATIVUS
54575-201HELMINTHOSPORIUM SATIVUMcochliobolus sativus

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