NDC 36987-2022

Nigrospora sphaerica

Nigrospora Sphaerica

Nigrospora sphaerica 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 Khuskia Oryzae.

Product ID36987-2022_23e797dd-af20-4ed3-8c4d-eed59804742e
NDC36987-2022
Product TypeHuman Prescription Drug
Proprietary NameNigrospora sphaerica
Generic NameNigrospora Sphaerica
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameKHUSKIA ORYZAE
Active Ingredient Strength20000 [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 36987-2022-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2022-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2022-1 [36987202201]

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

NDC 36987-2022-4 [36987202204]

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

NDC 36987-2022-3 [36987202203]

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

NDC 36987-2022-2 [36987202202]

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

Drug Details

Active Ingredients

IngredientStrength
KHUSKIA ORYZAE20000 [PNU]/mL

OpenFDA Data

SPL SET ID:cfe0440b-fd9e-413b-965c-0a7b5bfbba3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892481
  • 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 "Nigrospora sphaerica" or generic name "Nigrospora Sphaerica"

    NDCBrand NameGeneric Name
    36987-2019Nigrospora sphaericaNigrospora sphaerica
    36987-2020Nigrospora sphaericaNigrospora sphaerica
    36987-2021Nigrospora sphaericaNigrospora sphaerica
    36987-2022Nigrospora sphaericaNigrospora sphaerica
    36987-2023Nigrospora sphaericaNigrospora sphaerica
    36987-2024Nigrospora sphaericaNigrospora sphaerica
    36987-2025Nigrospora sphaericaNigrospora sphaerica
    36987-2026Nigrospora sphaericaNigrospora shaerica
    36987-2027Nigrospora sphaericaNigrospora sphaerica
    54575-212NIGROSPORA SPHAERICAkhuskia oryzae

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