NDC 36987-2401

Standardized Timothy Grass Pollen

Standardized Timothy Grass Pollen

Standardized Timothy Grass Pollen 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 Phleum Pratense Pollen.

Product ID36987-2401_1ec687f1-9d85-476a-83e1-59e2bdbeebbc
NDC36987-2401
Product TypeHuman Prescription Drug
Proprietary NameStandardized Timothy Grass Pollen
Generic NameStandardized Timothy Grass Pollen
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1998-02-10
Marketing CategoryBLA / BLA
Application NumberBLA102202
Labeler NameNelco Laboratories, Inc.
Substance NamePHLEUM PRATENSE POLLEN
Active Ingredient Strength100000 [BAU]/mL
Pharm ClassesStandardized 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 36987-2401-4

50 mL in 1 VIAL, MULTI-DOSE (36987-2401-4)
Marketing Start Date1998-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2401-3 [36987240103]

Standardized Timothy Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102202
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-02-10
Inactivation Date2019-10-21

NDC 36987-2401-2 [36987240102]

Standardized Timothy Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102202
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-02-10
Inactivation Date2019-10-21

NDC 36987-2401-4 [36987240104]

Standardized Timothy Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102202
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-02-10
Inactivation Date2019-10-21

NDC 36987-2401-1 [36987240101]

Standardized Timothy Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102202
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-02-10
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE POLLEN100000 [BAU]/mL

OpenFDA Data

SPL SET ID:6a9c78b4-97a6-4fbc-a072-8916f7232b1b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 853027
  • 851901
  • 851881
  • 853047
  • 854054
  • 853029
  • 851921
  • 854162
  • 852822
  • 852837
  • 897496
  • 851873
  • 853278
  • 851997
  • 852157
  • Pharmacological Class

    • 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 "Standardized Timothy Grass Pollen" or generic name "Standardized Timothy Grass Pollen"

    NDCBrand NameGeneric Name
    36987-2401Standardized Timothy Grass PollenStandardized Timothy Grass Pollen
    36987-2402Standardized Timothy Grass PollenStandardized Timothy Grass Pollen
    49288-0575Standardized Timothy Grass PollenStandardized Timothy Grass Pollen
    54575-107STANDARDIZED TIMOTHY GRASS POLLENPhleum pratense pollen

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