NDC 0268-1048

FAGUS GRANDIFOLIA POLLEN

Beech

FAGUS GRANDIFOLIA 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 Fagus Grandifolia Pollen.

Product ID0268-1048_152accc2-8563-4b11-9c7c-f61b002b30f8
NDC0268-1048
Product TypeNon-standardized Allergenic
Proprietary NameFAGUS GRANDIFOLIA POLLEN
Generic NameBeech
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameFAGUS GRANDIFOLIA 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
Listing Certified Through2022-12-31

Packaging

NDC 0268-1048-10

10 mL in 1 VIAL, MULTI-DOSE (0268-1048-10)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-1048-10 [00268104810]

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

NDC 0268-1048-50 [00268104850]

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

Drug Details

Active Ingredients

IngredientStrength
FAGUS GRANDIFOLIA 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 "FAGUS GRANDIFOLIA POLLEN" or generic name "Beech"

NDCBrand NameGeneric Name
0268-1046FAGUS GRANDIFOLIA POLLENBeech
0268-1047FAGUS GRANDIFOLIA POLLENBeech
0268-1048FAGUS GRANDIFOLIA POLLENBeech
0268-1049FAGUS GRANDIFOLIA POLLENBeech
0268-6607FAGUS GRANDIFOLIA POLLENBeech
0268-6684FAGUS GRANDIFOLIA POLLENBeech
54575-910AMERICAN BEECH POLLENfagus grandifolia pollen
0268-0034CENTER-AL - FAGUS GRANDIFOLIA POLLENFAGUS GRANDIFOLIA POLLEN

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