NDC 65044-0844

Standardized Grass Pollen, Grass Mix 4

Standardized Grass Pollen, Grass Mix 4

Standardized Grass Pollen, Grass Mix 4 is a Intradermal 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.

Product ID65044-0844_d35f56c5-a667-4175-83dc-963235f74ab6
NDC65044-0844
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Grass Mix 4
Generic NameStandardized Grass Pollen, Grass Mix 4
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103873
Labeler NameJubilant HollisterStier LLC
Substance NamePOA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN
Active Ingredient Strength250 [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]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-0844-5

5 mL in 1 VIAL (65044-0844-5)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0844-5 [65044084405]

Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15
Marketing End Date2019-11-21

Drug Details

Active Ingredients

IngredientStrength
POA PRATENSIS POLLEN250 [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]

NDC Crossover Matching brand name "Standardized Grass Pollen, Grass Mix 4" or generic name "Standardized Grass Pollen, Grass Mix 4"

NDCBrand NameGeneric Name
65044-0841Standardized Grass Pollen, Grass Mix 4Standardized Grass Pollen, Grass Mix 4
65044-0842Standardized Grass Pollen, Grass Mix 4Standardized Grass Pollen, Grass Mix 4
65044-0843Standardized Grass Pollen, Grass Mix 4Standardized Grass Pollen, Grass Mix 4
65044-0844Standardized Grass Pollen, Grass Mix 4Standardized Grass Pollen, Grass Mix 4

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