NDC 22840-1449

River Birch Pollen

Betula Nigra

River Birch Pollen is a Intradermal; Percutaneous; Subcutaneous Solution in the Non-standardized Allergenic category. It is labeled and distributed by Greer Laboratories, Inc.. The primary component is Betula Nigra Pollen.

Product ID22840-1449_83d281e9-375b-7e6c-e053-2991aa0a6f0e
NDC22840-1449
Product TypeNon-standardized Allergenic
Proprietary NameRiver Birch Pollen
Generic NameBetula Nigra
Dosage FormSolution
Route of AdministrationINTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1981-09-15
Marketing CategoryBLA / BLA
Application NumberBLA101833
Labeler NameGreer Laboratories, Inc.
Substance NameBETULA NIGRA POLLEN
Active Ingredient Strength0 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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 22840-1449-2

10 mL in 1 VIAL, MULTI-DOSE (22840-1449-2)
Marketing Start Date1981-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 22840-1449-2 [22840144902]

River Birch Pollen SOLUTION
Marketing CategoryBLA
Application NumberBLA101833
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1981-09-15

NDC 22840-1449-4 [22840144904]

River Birch Pollen SOLUTION
Marketing CategoryBLA
Application NumberBLA101833
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1981-09-15

Drug Details

Active Ingredients

IngredientStrength
BETULA NIGRA POLLEN.1 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]

NDC Crossover Matching brand name "River Birch Pollen" or generic name "Betula Nigra"

NDCBrand NameGeneric Name
22840-1449River Birch PollenBetula nigra
22840-1450River Birch PollenBetula nigra
22840-1451River Birch PollenBetula nigra
22840-1452River Birch PollenBetula nigra
22840-4493River Birch PollenBetula nigra
22840-5413River Birch PollenBetula nigra
54575-912RIVER BIRCH POLLENbetula nigra pollen
49643-443River/Red Birch PollenBetula nigra

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