NDC 36987-2158

Oat Smut

Oat Smut

Oat Smut 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 Ustilago Avenae.

Product ID36987-2158_9010bf62-c443-49a9-b8f8-fa8dd9223885
NDC36987-2158
Product TypeHuman Prescription Drug
Proprietary NameOat Smut
Generic NameOat Smut
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameUSTILAGO AVENAE
Active Ingredient Strength40000 [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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2158-3

30 mL in 1 VIAL, MULTI-DOSE (36987-2158-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2158-1 [36987215801]

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

NDC 36987-2158-2 [36987215802]

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

NDC 36987-2158-4 [36987215804]

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

NDC 36987-2158-3 [36987215803]

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

Drug Details

Active Ingredients

IngredientStrength
USTILAGO AVENAE40000 [PNU]/mL

OpenFDA Data

SPL SET ID:8559987a-4127-45d1-81c8-9bce75e85db3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1006305
  • 967955
  • 968200
  • 967545
  • 967910
  • 1011993
  • 1012320
  • 889536
  • 1012106
  • 966960
  • 307874
  • 968458
  • 889577
  • 1010862
  • 1010908
  • 968486
  • 1012053
  • 967047
  • 1012154
  • 1012039
  • 1012037
  • 1006337
  • 1012174
  • 1006294
  • 889606
  • 966691
  • 968540
  • 966668
  • 967059
  • 905081
  • 1012049
  • 968153
  • 1012045
  • 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 "Oat Smut" or generic name "Oat Smut"

    NDCBrand NameGeneric Name
    22840-5651Oat SmutUstilago avenae
    36987-2154Oat SmutOat Smut
    36987-2155Oat SmutOat Smut
    36987-2156Oat SmutOat Smut
    36987-2157Oat SmutOat Smut
    36987-2158Oat SmutOat Smut
    36987-2159Oat SmutOat Smut
    36987-2160Oat SmutOat Smut
    36987-2161Oat SmutOat Smut
    36987-2162Oat SmutOat Smut
    49288-0342Oat SmutOat Smut

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