NDC 49288-0346

Cultivated Oat Pollen

Cultivated Oat Pollen

Cultivated Oat Pollen is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Avena Sativa Pollen.

Product ID49288-0346_0247493a-8221-44f5-afa6-071bde3bfac2
NDC49288-0346
Product TypeHuman Prescription Drug
Proprietary NameCultivated Oat Pollen
Generic NameCultivated Oat Pollen
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-23
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameAVENA SATIVA 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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0346-2

5 mL in 1 VIAL, MULTI-DOSE (49288-0346-2)
Marketing Start Date1974-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0346-3 [49288034603]

Cultivated Oat Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0346-2 [49288034602]

Cultivated Oat Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0346-4 [49288034604]

Cultivated Oat Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0346-1 [49288034601]

Cultivated Oat Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0346-5 [49288034605]

Cultivated Oat Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
AVENA SATIVA POLLEN.05 g/mL

OpenFDA Data

SPL SET ID:c7d383a6-94b8-4101-8a4c-fa7747a21468
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889573
  • 852676
  • 852517
  • 852346
  • 852228
  • 852220
  • 1232641
  • 1006509
  • 1115952
  • 889671
  • 898407
  • 1098458
  • 852117
  • 852018
  • 852332
  • 852662
  • 852139
  • 852135
  • 1014777
  • 1014738
  • 1014734
  • 852700
  • 898132
  • Pharmacological Class

    • 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 Oat Pollen" or generic name "Cultivated Oat Pollen"

    NDCBrand NameGeneric Name
    49288-0346Cultivated Oat PollenCultivated Oat Pollen
    49643-322Cultivated Oat PollenAvena sativa

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