NDC 65044-1168

Pollens - Trees, Birch Mix

Birch Mix

Pollens - Trees, Birch Mix is a Percutaneous; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Betula Papyrifera Pollen; Betula Pendula Pollen; Betula Nigra Pollen.

Product ID65044-1168_542aadd7-a419-42a2-a51d-25c08491a652
NDC65044-1168
Product TypeNon-standardized Allergenic
Proprietary NamePollens - Trees, Birch Mix
Generic NameBirch Mix
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1941-04-19
Marketing CategoryBLA / BLA
Application NumberBLA103888
Labeler NameJubilant HollisterStier LLC
Substance NameBETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN
Active Ingredient Strength0 g/mL; g/mL; g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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 65044-1168-2

10 mL in 1 VIAL (65044-1168-2)
Marketing Start Date1941-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-1168-4 [65044116804]

Pollens - Trees, Birch Mix INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

NDC 65044-1168-2 [65044116802]

Pollens - Trees, Birch Mix INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

NDC 65044-1168-3 [65044116803]

Pollens - Trees, Birch Mix INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

Drug Details

Active Ingredients

IngredientStrength
BETULA PAPYRIFERA POLLEN.05 g/mL

Pharmacological Class

  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • 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 "Pollens - Trees, Birch Mix" or generic name "Birch Mix"

NDCBrand NameGeneric Name
65044-1168Pollens - Trees, Birch MixBirch Mix
65044-1169Pollens - Trees, Birch MixBirch Mix
65044-1170Pollens - Trees, Birch MixBirch Mix
65044-1171Pollens - Trees, Birch MixBirch Mix
65044-1172Pollens - Trees, Birch MixBirch Mix

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