NDC 65044-0790

Standardized Grass Pollen, Ryegrass

Standardized Grass Pollen, Ryegrass

Standardized Grass Pollen, Ryegrass is a Intradermal Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Lolium Perenne Pollen.

Product ID65044-0790_76062435-a734-468d-88f3-d07042e05fea
NDC65044-0790
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Ryegrass
Generic NameStandardized Grass Pollen, Ryegrass
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103877
Labeler NameJubilant HollisterStier LLC
Substance NameLOLIUM PERENNE POLLEN
Active Ingredient Strength1000 [BAU]/mL
Pharm ClassesStandardized 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 65044-0790-5

5 mL in 1 VIAL (65044-0790-5)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0790-5 [65044079005]

Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103877
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LOLIUM PERENNE POLLEN1000 [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]

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

NDCBrand NameGeneric Name
65044-0787Standardized Grass Pollen, RyegrassStandardized Grass Pollen, Ryegrass
65044-0788Standardized Grass Pollen, RyegrassStandardized Grass Pollen, Ryegrass
65044-0789Standardized Grass Pollen, RyegrassStandardized Grass Pollen, Ryegrass
65044-0790Standardized Grass Pollen, RyegrassStandardized Grass Pollen, Ryegrass

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