NDC 36987-1892

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 ID36987-1892_d12744f1-9486-4d31-b57b-38009e772ed7
NDC36987-1892
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 36987-1892-4

50 mL in 1 VIAL, MULTI-DOSE (36987-1892-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1892-2 [36987189202]

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

NDC 36987-1892-4 [36987189204]

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

NDC 36987-1892-3 [36987189203]

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

NDC 36987-1892-1 [36987189201]

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.1 g/mL

OpenFDA Data

SPL SET ID:b2648ee2-1d05-4f7d-b6f5-a6cad19e2bfd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854133
  • 892677
  • 852469
  • 1006326
  • 852105
  • 968480
  • 852401
  • 1012148
  • 1011991
  • 852375
  • 968143
  • 1010906
  • 967949
  • 967869
  • 901848
  • 889542
  • 852763
  • 968210
  • 1006290
  • 967534
  • 905075
  • 1012033
  • 852192
  • 968448
  • 966685
  • 889587
  • 889620
  • 995697
  • 1012102
  • 852060
  • 967053
  • 967032
  • 1012043
  • 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

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