NDC 65044-0545

Standardized Grass Pollen, Bluegrass, Kentucky June

Standardized Grass Pollen, Bluegrass, Kentucky June

Standardized Grass Pollen, Bluegrass, Kentucky June is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen.

Product ID65044-0545_0cdf6656-6263-450e-a312-5cb125444591
NDC65044-0545
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Bluegrass, Kentucky June
Generic NameStandardized Grass Pollen, Bluegrass, Kentucky June
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103873
Labeler NameJubilant HollisterStier LLC
Substance NamePOA PRATENSIS POLLEN
Active Ingredient Strength10000 [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 65044-0545-1

5 mL in 1 VIAL (65044-0545-1)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0545-3 [65044054503]

Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0545-4 [65044054504]

Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0545-2 [65044054502]

Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0545-1 [65044054501]

Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103873
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

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]

NDC Crossover Matching brand name "Standardized Grass Pollen, Bluegrass, Kentucky June" or generic name "Standardized Grass Pollen, Bluegrass, Kentucky June"

NDCBrand NameGeneric Name
65044-0545Standardized Grass Pollen, Bluegrass, Kentucky JuneStandardized Grass Pollen, Bluegrass, Kentucky June
65044-0546Standardized Grass Pollen, Bluegrass, Kentucky JuneStandardized Grass Pollen, Bluegrass, Kentucky June
65044-0547Standardized Grass Pollen, Bluegrass, Kentucky JuneStandardized Grass Pollen, Bluegrass, Kentucky June
65044-0548Standardized Grass Pollen, Bluegrass, Kentucky JuneStandardized Grass Pollen, Bluegrass, Kentucky June

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