NDC 65044-0788

Standardized Grass Pollen, Ryegrass

Standardized Grass Pollen, Ryegrass

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

Product ID65044-0788_0cdf6656-6263-450e-a312-5cb125444591
NDC65044-0788
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Ryegrass
Generic NameStandardized Grass Pollen, Ryegrass
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103877
Labeler NameJubilant HollisterStier LLC
Substance NameLOLIUM PERENNE POLLEN
Active Ingredient Strength100000 [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 Through2022-12-31

Packaging

NDC 65044-0788-1

5 mL in 1 VIAL (65044-0788-1)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0788-1 [65044078801]

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

NDC 65044-0788-3 [65044078803]

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

NDC 65044-0788-4 [65044078804]

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

NDC 65044-0788-2 [65044078802]

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

Drug Details

Active Ingredients

IngredientStrength
LOLIUM PERENNE POLLEN100000 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.