NDC 0268-0956

STEMPHYLIUM SOLANI

Stemphylium Solani

STEMPHYLIUM SOLANI is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Stemphylium Solani.

Product ID0268-0956_152accc2-8563-4b11-9c7c-f61b002b30f8
NDC0268-0956
Product TypeNon-standardized Allergenic
Proprietary NameSTEMPHYLIUM SOLANI
Generic NameStemphylium Solani
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameSTEMPHYLIUM SOLANI
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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0268-0956-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0956-10)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0956-10 [00268095610]

STEMPHYLIUM SOLANI INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-0956-50 [00268095650]

STEMPHYLIUM SOLANI INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
STEMPHYLIUM SOLANI10000 [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 "STEMPHYLIUM SOLANI" or generic name "Stemphylium Solani"

NDCBrand NameGeneric Name
0268-0955STEMPHYLIUM SOLANISTEMPHYLIUM SOLANI
0268-0956STEMPHYLIUM SOLANISTEMPHYLIUM SOLANI
0268-0957STEMPHYLIUM SOLANISTEMPHYLIUM SOLANI
0268-0958STEMPHYLIUM SOLANISTEMPHYLIUM SOLANI
0268-0959STEMPHYLIUM SOLANISTEMPHYLIUM SOLANI
0268-6553STEMPHYLIUM SOLANIStemphylium spp
0268-6555STEMPHYLIUM SOLANIStemphylium spp
22840-2635Stemphylium solaniStemphylium solani
22840-2636Stemphylium solaniStemphylium solani
22840-2637Stemphylium solaniStemphylium solani
22840-2638Stemphylium solaniStemphylium solani
22840-5637Stemphylium solaniStemphylium solani
49643-173Stemphylium solaniStemphylium solani

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