NDC 0268-8027

GRASS MIX Number 4-S

Agrostis Gigantea Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen

GRASS MIX Number 4-S is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Poa Pratensis Pollen; Agrostis Gigantea Pollen; Dactylis Glomerata Pollen; Phleum Pratense Pollen.

Product ID0268-8027_0d292dae-220a-45c7-94cb-cade20038419
NDC0268-8027
Product TypeStandardized Allergenic
Proprietary NameGRASS MIX Number 4-S
Generic NameAgrostis Gigantea Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103052
Labeler NameALK-Abello, Inc.
Substance NamePOA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN
Active Ingredient Strength25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Pharm ClassesStandardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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 Through2021-12-31

Packaging

NDC 0268-8027-50

53 mL in 1 VIAL (0268-8027-50)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8027-50 [00268802750]

GRASS MIX Number 4-S INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103052
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

Drug Details

Active Ingredients

IngredientStrength
POA PRATENSIS POLLEN25000 [BAU]/mL

Pharmacological Class

  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • 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 "GRASS MIX Number 4-S" or generic name "Agrostis Gigantea Pollen, Dactylis Glomerata Pollen, Phleum Pratense Pollen And Poa Pratensis Pollen"

NDCBrand NameGeneric Name
0268-8026GRASS MIX Number 4-SAGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN
0268-8027GRASS MIX Number 4-SAGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN
0268-8077MIDWEST MIX OF STANDARD GRASSAGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN

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