NDC 0268-8073

MIX OF 5 STANDARD GRASS POLLEN

Agrostis Gigantea Pollen, Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen

MIX OF 5 STANDARD GRASS POLLEN is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen; Dactylis Glomerata Pollen; Poa Pratensis Pollen; Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen.

Product ID0268-8073_0d292dae-220a-45c7-94cb-cade20038419
NDC0268-8073
Product TypeStandardized Allergenic
Proprietary NameMIX OF 5 STANDARD GRASS POLLEN
Generic NameAgrostis Gigantea Pollen, Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103058
Labeler NameALK-Abello, Inc.
Substance NamePHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA 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],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 Through2021-12-31

Packaging

NDC 0268-8073-06

5.5 mL in 1 VIAL (0268-8073-06)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8073-50 [00268807350]

MIX OF 5 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

NDC 0268-8073-06 [00268807306]

MIX OF 5 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

NDC 0268-8073-10 [00268807310]

MIX OF 5 STANDARD GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE 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]
  • 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]

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