NDC 0268-1066

BETULA NIGRA POLLEN

Birch River Red

BETULA NIGRA POLLEN is a Subcutaneous 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 ID0268-1066_152accc2-8563-4b11-9c7c-f61b002b30f8
NDC0268-1066
Product TypeNon-standardized Allergenic
Proprietary NameBETULA NIGRA POLLEN
Generic NameBirch River Red
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1965-01-01
Marketing End Date2021-11-30
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameBETULA NIGRA POLLEN
Active Ingredient Strength40000 [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

Packaging

NDC 0268-1066-10

10 mL in 1 VIAL, MULTI-DOSE (0268-1066-10)
Marketing Start Date1965-01-01
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-1066-10 [00268106610]

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

NDC 0268-1066-50 [00268106650]

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 POLLEN40000 [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 "Birch River 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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