NDC 36987-2365

Cultivated Rye

Cultivated Rye

Cultivated Rye 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 Secale Cereale Pollen.

Product ID36987-2365_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac
NDC36987-2365
Product TypeHuman Prescription Drug
Proprietary NameCultivated Rye
Generic NameCultivated Rye
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameSECALE CEREALE POLLEN
Active Ingredient Strength10000 [PNU]/mL
Pharm ClassesAllergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2365-4

50 mL in 1 VIAL, MULTI-DOSE (36987-2365-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2365-1 [36987236501]

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

NDC 36987-2365-3 [36987236503]

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

NDC 36987-2365-2 [36987236502]

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

NDC 36987-2365-4 [36987236504]

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

Drug Details

Active Ingredients

IngredientStrength
SECALE CEREALE POLLEN10000 [PNU]/mL

OpenFDA Data

SPL SET ID:0e31061a-dd28-4932-ae30-f95c3c1f1b11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044502
  • 897349
  • 889567
  • 1044523
  • 897357
  • 889668
  • 900010
  • 1014345
  • 899974
  • 1044252
  • 1000015
  • 900155
  • 898134
  • 897331
  • 1044494
  • 889532
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    22840-1566Cultivated RyeSecale cereale
    22840-1583Cultivated RyeSecale cereale
    22840-1584Cultivated RyeSecale cereale
    22840-1585Cultivated RyeSecale cereale
    22840-1586Cultivated RyeSecale cereale
    22840-5522Cultivated RyeSecale cereale
    36987-2365Cultivated RyeCultivated Rye
    36987-2366Cultivated RyeCultivated Rye
    36987-2367Cultivated RyeCultivated Rye
    36987-2368Cultivated RyeCultivated Rye
    36987-2369Cultivated RyeCultivated Rye
    36987-2370Cultivated RyeCultivated Rye
    36987-2371Cultivated RyeCultivated Rye
    36987-2372Cultivated RyeCultivated Rye

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