NDC 36987-1890

Aspergillus niger

Aspergillus Niger

Aspergillus niger 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 Aspergillus Niger Var. Niger.

Product ID36987-1890_c1989e1c-0fcf-475f-9601-72f8c842e9d8
NDC36987-1890
Product TypeHuman Prescription Drug
Proprietary NameAspergillus niger
Generic NameAspergillus Niger
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameASPERGILLUS NIGER VAR. NIGER
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1890-3

30 mL in 1 VIAL, MULTI-DOSE (36987-1890-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1890-3 [36987189003]

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

NDC 36987-1890-1 [36987189001]

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

NDC 36987-1890-2 [36987189002]

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

NDC 36987-1890-4 [36987189004]

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

Drug Details

Active Ingredients

IngredientStrength
ASPERGILLUS NIGER VAR. NIGER.05 g/mL

OpenFDA Data

SPL SET ID:c82c1c56-bfd7-438e-93cd-49ab716e45e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1006300
  • 1012146
  • 852041
  • 968203
  • 1006288
  • 852243
  • 314941
  • 967777
  • 968478
  • 889590
  • 1011974
  • 1011976
  • 1011972
  • 1012035
  • 1010904
  • 1012051
  • 968133
  • 1012171
  • 1006321
  • 967947
  • 967532
  • 905073
  • 966683
  • 968544
  • 852800
  • 883409
  • 968440
  • 968429
  • 967038
  • 967051
  • 1012047
  • 1012041
  • 967985
  • 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 "Aspergillus niger" or generic name "Aspergillus Niger"

    NDCBrand NameGeneric Name
    22840-1625Aspergillus nigerAspergillus niger
    22840-1626Aspergillus nigerAspergillus niger
    22840-1627Aspergillus nigerAspergillus niger
    22840-1628Aspergillus nigerAspergillus niger
    22840-5606Aspergillus nigerAspergillus niger
    36987-1889Aspergillus nigerAspergillus niger
    36987-1885Aspergillus nigerAspergillus niger
    36987-1887Aspergillus nigerAspergillus niger
    36987-1890Aspergillus nigerAspergillus niger
    36987-1891Aspergillus nigerAspergillus niger
    36987-1886Aspergillus nigerAspergillus niger
    36987-1892Aspergillus nigerAspergillus niger
    36987-1884Aspergillus nigerAspergillus niger
    36987-1888Aspergillus nigerAspergillus niger
    44911-0173Aspergillus NigerAspergillus Niger
    49288-0033Aspergillus nigerAspergillus niger
    49288-0032Aspergillus nigerAspergillus niger
    49643-162Aspergillus nigerAspergillus niger
    54575-184ASPERGILLUS NIGERASPERGILLUS NIGER
    0268-0827ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
    0268-0828ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
    0268-0829ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
    0268-0830ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
    0268-6507ASPERGILLUS NIGER VAR NIGERAspergillus Niger
    0268-6508ASPERGILLUS NIGER VAR NIGERAspergillus Niger

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