NDC 22840-0205

Standardized Orchard Grass Pollen

Dactylis Glomerata

Standardized Orchard Grass Pollen is a Intradermal; Percutaneous; Subcutaneous Solution in the Standardized Allergenic category. It is labeled and distributed by Greer Laboratories, Inc.. The primary component is Dactylis Glomerata Pollen.

Product ID22840-0205_60b8218f-84f1-1acc-e053-2991aa0a2795
NDC22840-0205
Product TypeStandardized Allergenic
Proprietary NameStandardized Orchard Grass Pollen
Generic NameDactylis Glomerata
Dosage FormSolution
Route of AdministrationINTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1968-09-15
Marketing CategoryBLA / BLA
Application NumberBLA101839
Labeler NameGreer Laboratories, Inc.
Substance NameDACTYLIS GLOMERATA POLLEN
Active Ingredient Strength10000 [BAU]/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 Through2019-12-31

Packaging

NDC 22840-0205-2

10 mL in 1 VIAL, MULTI-DOSE (22840-0205-2)
Marketing Start Date1968-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 22840-0205-4 [22840020504]

Standardized Orchard Grass Pollen SOLUTION
Marketing CategoryBLA
Application NumberBLA101839
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1968-09-15

NDC 22840-0205-5 [22840020505]

Standardized Orchard Grass Pollen SOLUTION
Marketing CategoryBLA
Application NumberBLA101839
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1968-09-15

NDC 22840-0205-2 [22840020502]

Standardized Orchard Grass Pollen SOLUTION
Marketing CategoryBLA
Application NumberBLA101839
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1968-09-15

Drug Details

Active Ingredients

IngredientStrength
DACTYLIS GLOMERATA POLLEN10000 [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]

NDC Crossover Matching brand name "Standardized Orchard Grass Pollen" or generic name "Dactylis Glomerata"

NDCBrand NameGeneric Name
22840-0205Standardized Orchard Grass PollenDactylis glomerata
22840-0206Standardized Orchard Grass PollenDactylis glomerata
36987-2345Standardized Orchard Grass PollenStandardized Orchard Grass Pollen
36987-2346Standardized Orchard Grass PollenStandardized Orchard Grass Pollen
49288-0341Standardized Orchard Grass PollenStandardized Orchard Grass Pollen
54575-097STANDARDIZED ORCHARD GRASS POLLENDactylis glomerata pollen
49643-343Standardized Orchard GrassDactylis glomerata

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