NDC 0268-6687

BETULA NIGRA POLLEN

River Birch Red

BETULA NIGRA POLLEN is a Intradermal Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Betula Nigra Pollen.

Product ID0268-6687_06c812ac-2bfd-444c-b2b9-50076167486c
NDC0268-6687
Product TypeNon-standardized Allergenic
Proprietary NameBETULA NIGRA POLLEN
Generic NameRiver Birch Red
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameBETULA NIGRA POLLEN
Active Ingredient Strength1000 [PNU]/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 Through2022-12-31

Packaging

NDC 0268-6687-05

5 mL in 1 VIAL, MULTI-DOSE (0268-6687-05)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-6687-05 [00268668705]

BETULA NIGRA POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
BETULA NIGRA POLLEN1000 [PNU]/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]

NDC Crossover Matching brand name "BETULA NIGRA POLLEN" or generic name "River Birch Red"

NDCBrand NameGeneric Name
0268-1062BETULA NIGRA POLLENBirch River Red
0268-1063BETULA NIGRA POLLENBirch River Red
0268-1064BETULA NIGRA POLLENBirch River Red
0268-1065BETULA NIGRA POLLENBirch River Red
0268-1066BETULA NIGRA POLLENBirch River Red
0268-6609BETULA NIGRA POLLENRiver Birch Red
0268-6687BETULA NIGRA POLLENRiver Birch Red
54575-912RIVER BIRCH POLLENbetula nigra pollen

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