NDC 65044-0857

Pollens - Grasses, Southern Grass Mix

Pollens - Grasses, Southern Grass Mix

Pollens - Grasses, Southern Grass Mix is a Percutaneous Injection, Solution in the Non-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; Sorghum Halepense Pollen; Cynodon Dactylon Pollen.

Product ID65044-0857_7bd74194-f6a5-47fd-85bc-abc20faa6b2d
NDC65044-0857
Product TypeNon-standardized Allergenic
Proprietary NamePollens - Grasses, Southern Grass Mix
Generic NamePollens - Grasses, Southern Grass Mix
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1941-04-19
Marketing CategoryBLA / BLA
Application NumberBLA103888
Labeler NameJubilant HollisterStier LLC
Substance NamePOA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN
Active Ingredient Strength10000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65044-0857-1

5 mL in 1 VIAL (65044-0857-1)
Marketing Start Date1941-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0857-1 [65044085701]

Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

Drug Details

Active Ingredients

IngredientStrength
POA PRATENSIS POLLEN10000 [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]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]

NDC Crossover Matching brand name "Pollens - Grasses, Southern Grass Mix" or generic name "Pollens - Grasses, Southern Grass Mix"

NDCBrand NameGeneric Name
65044-0854Pollens - Grasses, Southern Grass MixPollens - Grasses, Southern Grass Mix
65044-0855Pollens - Grasses, Southern Grass MixPollens - Grasses, Southern Grass Mix
65044-0856Pollens - Grasses, Southern Grass MixPollens - Grasses, Southern Grass Mix
65044-0857Pollens - Grasses, Southern Grass MixPollens - Grasses, Southern Grass Mix

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