NDC 65044-0777

Standardized Grass Pollen, Redtop

Standardized Grass Pollen, Redtop

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

Product ID65044-0777_0cdf6656-6263-450e-a312-5cb125444591
NDC65044-0777
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Redtop
Generic NameStandardized Grass Pollen, Redtop
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103876
Labeler NameJubilant HollisterStier LLC
Substance NameAGROSTIS GIGANTEA POLLEN
Active Ingredient Strength10000 [BAU]/mL
Pharm ClassesStandardized 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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65044-0777-1

5 mL in 1 VIAL (65044-0777-1)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0777-3 [65044077703]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103876
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0777-2 [65044077702]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103876
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0777-4 [65044077704]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103876
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0777-1 [65044077701]

Standardized Grass Pollen, Redtop INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103876
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

Drug Details

Active Ingredients

IngredientStrength
AGROSTIS GIGANTEA POLLEN10000 [BAU]/mL

Pharmacological Class

  • 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]

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

NDCBrand NameGeneric Name
65044-0777Standardized Grass Pollen, RedtopStandardized Grass Pollen, Redtop
65044-0778Standardized Grass Pollen, RedtopStandardized Grass Pollen, Redtop
65044-0779Standardized Grass Pollen, RedtopStandardized Grass Pollen, Redtop
65044-0780Standardized Grass Pollen, RedtopStandardized Grass Pollen, Redtop

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