NDC 0268-0100

CENTER-AL - ACER SACCHARUM POLLEN

Acer Saccharum Pollen

CENTER-AL - ACER SACCHARUM 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 Acer Saccharum Pollen.

Product ID0268-0100_12a51e21-1817-4ded-8bf2-a2ad5fc6525c
NDC0268-0100
Product TypeNon-standardized Allergenic
Proprietary NameCENTER-AL - ACER SACCHARUM POLLEN
Generic NameAcer Saccharum Pollen
Dosage FormInjection, Suspension
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1975-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameACER SACCHARUM POLLEN
Active Ingredient Strength10000 [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 0268-0100-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0100-10)
Marketing Start Date1975-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0100-30 [00268010030]

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

NDC 0268-0100-10 [00268010010]

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

Drug Details

Active Ingredients

IngredientStrength
ACER SACCHARUM POLLEN10000 [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 "CENTER-AL - ACER SACCHARUM POLLEN" or generic name "Acer Saccharum Pollen"

NDCBrand NameGeneric Name
0268-0100CENTER-AL - ACER SACCHARUM POLLENACER SACCHARUM POLLEN
54575-941SUGAR HARD MAPLE POLLENacer saccharum pollen

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