NDC 65044-0831

Standardized Grass Pollen, Timothy

Standardized Grass Pollen, Timothy

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

Product ID65044-0831_0cdf6656-6263-450e-a312-5cb125444591
NDC65044-0831
Product TypeStandardized Allergenic
Proprietary NameStandardized Grass Pollen, Timothy
Generic NameStandardized Grass Pollen, Timothy
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1998-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103879
Labeler NameJubilant HollisterStier LLC
Substance NamePHLEUM PRATENSE 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 65044-0831-1

5 mL in 1 VIAL (65044-0831-1)
Marketing Start Date1998-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-0831-4 [65044083104]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103879
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0831-2 [65044083102]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103879
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0831-1 [65044083101]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103879
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

NDC 65044-0831-3 [65044083103]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103879
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1998-01-15

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE 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, Timothy" or generic name "Standardized Grass Pollen, Timothy"

NDCBrand NameGeneric Name
65044-0831Standardized Grass Pollen, TimothyStandardized Grass Pollen, Timothy
65044-0832Standardized Grass Pollen, TimothyStandardized Grass Pollen, Timothy
65044-0833Standardized Grass Pollen, TimothyStandardized Grass Pollen, Timothy
65044-0834Standardized Grass Pollen, TimothyStandardized Grass Pollen, Timothy

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