NDC 0268-0103

CENTER-AL - FESTUCA PRATENSIS POLLEN

Festuca Pratensis Pollen

CENTER-AL - FESTUCA PRATENSIS POLLEN is a Subcutaneous Injection, Suspension in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Festuca Pratensis Pollen.

Product ID0268-0103_12a51e21-1817-4ded-8bf2-a2ad5fc6525c
NDC0268-0103
Product TypeNon-standardized Allergenic
Proprietary NameCENTER-AL - FESTUCA PRATENSIS POLLEN
Generic NameFestuca Pratensis Pollen
Dosage FormInjection, Suspension
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1975-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameFESTUCA PRATENSIS POLLEN
Active Ingredient Strength20000 [PNU]/mL
Pharm ClassesStandardized 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 0268-0103-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0103-10)
Marketing Start Date1975-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0103-10 [00268010310]

CENTER-AL - FESTUCA PRATENSIS POLLEN INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1975-01-15

Drug Details

Active Ingredients

IngredientStrength
FESTUCA PRATENSIS POLLEN20000 [PNU]/mL

Pharmacological Class

  • 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 "CENTER-AL - FESTUCA PRATENSIS POLLEN" or generic name "Festuca Pratensis Pollen"

NDCBrand NameGeneric Name
0268-0103CENTER-AL - FESTUCA PRATENSIS POLLENFESTUCA PRATENSIS POLLEN
0268-0104CENTER-AL - FESTUCA PRATENSIS POLLENFESTUCA PRATENSIS POLLEN
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