NDC 65044-0846

Standardized Grass Pollen, Grass Mix 5

Standardized Grass Pollen, Grass Mix 5

Standardized Grass Pollen, Grass Mix 5 is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen; Dactylis Glomerata Pollen; Agrostis Gigantea Pollen; Phleum Pratense Pollen; Anthoxanthum Odoratum Pollen.

Product ID65044-0846_d35f56c5-a667-4175-83dc-963235f74ab6
NDC65044-0846
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Grass Mix 5
Generic NameStandardized Grass Pollen, Grass Mix 5
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1998-01-05
Marketing CategoryBLA / BLA
Application NumberBLA103873
Labeler NameJubilant HollisterStier LLC
Substance NamePOA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN
Active Ingredient Strength20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Pharm ClassesStandardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-0846-2

10 mL in 1 VIAL (65044-0846-2)
Marketing Start Date1998-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0846-4 [65044084604]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-05
Marketing End Date2019-11-21

NDC 65044-0846-2 [65044084602]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-05
Marketing End Date2019-11-21

NDC 65044-0846-1 [65044084601]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-05
Marketing End Date2019-11-21

NDC 65044-0846-3 [65044084603]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-05
Marketing End Date2019-11-21

Drug Details

Active Ingredients

IngredientStrength
POA PRATENSIS POLLEN20000 [BAU]/mL

Pharmacological Class

  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • 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 Grass Pollen, Grass Mix 5" or generic name "Standardized Grass Pollen, Grass Mix 5"

NDCBrand NameGeneric Name
65044-0845Standardized Grass Pollen, Grass Mix 5Standardized Grass Pollen, Grass Mix 5
65044-0846Standardized Grass Pollen, Grass Mix 5Standardized Grass Pollen, Grass Mix 5
65044-0847Standardized Grass Pollen, Grass Mix 5Standardized Grass Pollen, Grass Mix 5
65044-0848Standardized Grass Pollen, Grass Mix 5Standardized Grass Pollen, Grass Mix 5

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