NDC 36987-2027

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 ID36987-2027_333d60d2-2a8c-4a82-922b-490696e55e89
NDC36987-2027
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 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 36987-2027-3

30 mL in 1 VIAL, MULTI-DOSE (36987-2027-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2027-4 [36987202704]

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

NDC 36987-2027-3 [36987202703]

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

NDC 36987-2027-2 [36987202702]

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

NDC 36987-2027-1 [36987202701]

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 ORYZAE.1 g/mL

OpenFDA Data

SPL SET ID:0668040a-ac04-473c-977f-8c51b7123d46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892348
  • 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

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