NDC 0268-8036

MIXED ASPERGILLUS

Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus

MIXED ASPERGILLUS is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Aspergillus Niger Var. Niger; Aspergillus Repens; Aspergillus Flavus Var. Oryzae; Aspergillus Terreus.

Product ID0268-8036_31222992-de8e-4717-ac14-f2214d9ef672
NDC0268-8036
Product TypeNon-standardized Allergenic
Proprietary NameMIXED ASPERGILLUS
Generic NameAspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1998-02-23
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS
Active Ingredient Strength10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [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],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Fungal Proteins [CS],Allergens [CS],Non-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 Through2021-12-31

Packaging

NDC 0268-8036-10

10.5 mL in 1 VIAL (0268-8036-10)
Marketing Start Date1998-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8036-10 [00268803610]

MIXED ASPERGILLUS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1998-02-23

Drug Details

Active Ingredients

IngredientStrength
ASPERGILLUS NIGER VAR. NIGER10000 [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]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Non-Standardized Fungal Allergenic Extract [EPC]
  • Fungal Proteins [CS]
  • Allergens [CS]
  • 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 "MIXED ASPERGILLUS" or generic name "Aspergillus Niger, Aspergillus Repens, Aspergillus Oryzae, Aspergillus Terreus"

NDCBrand NameGeneric Name
0268-0970MIXED ASPERGILLUSMIXED ASPERGILLUS
0268-6559MIXED ASPERGILLUSMIXED ASPERGILLUS
0268-8034MIXED ASPERGILLUSASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS
0268-8035MIXED ASPERGILLUSASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS
0268-8036MIXED ASPERGILLUSASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS
0268-8037MIXED ASPERGILLUSASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS

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