NDC 36987-2418

Cultivated Wheat

Cultivated Wheat

Cultivated Wheat 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 Triticum Aestivum Pollen.

Product ID36987-2418_b28ad23e-222c-49fb-8631-a50fe06898eb
NDC36987-2418
Product TypeHuman Prescription Drug
Proprietary NameCultivated Wheat
Generic NameCultivated Wheat
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameTRITICUM AESTIVUM POLLEN
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2418-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2418-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2418-1 [36987241801]

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

NDC 36987-2418-3 [36987241803]

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

NDC 36987-2418-2 [36987241802]

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

NDC 36987-2418-4 [36987241804]

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

Drug Details

Active Ingredients

IngredientStrength
TRITICUM AESTIVUM POLLEN.1 g/mL

OpenFDA Data

SPL SET ID:701a1bc2-06dd-40e3-a7ff-1ac9d349242e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889571
  • 1044500
  • 1044521
  • 900008
  • 889671
  • 897347
  • 897355
  • 899972
  • 1014695
  • 897329
  • 1044240
  • 889534
  • 1044250
  • 900153
  • 898132
  • 1044492
  • Pharmacological Class

    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]

    NDC Crossover Matching brand name "Cultivated Wheat" or generic name "Cultivated Wheat"

    NDCBrand NameGeneric Name
    22840-1567Cultivated WheatTriticum aestivum
    22840-1568Cultivated WheatTriticum aestivum
    22840-1587Cultivated WheatTriticum aestivum
    22840-1588Cultivated WheatTriticum aestivum
    22840-1589Cultivated WheatTriticum aestivum
    22840-1590Cultivated WheatTriticum aestivum
    22840-5523Cultivated WheatTriticum aestivum
    36987-2411Cultivated WheatCultivated Wheat
    36987-2412Cultivated WheatCultivated Wheat
    36987-2413Cultivated WheatCultivated Wheat
    36987-2414Cultivated WheatCultivated Wheat
    36987-2415Cultivated WheatCultivated Wheat
    36987-2416Cultivated WheatCultivated Wheat
    36987-2417Cultivated WheatCultivated Wheat
    36987-2418Cultivated WheatCultivated Wheat
    49288-0608Cultivated WheatCultivated Wheat

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