NDC 49288-0063

Standardized Bermuda Grass Pollen

Standardized Bermuda Grass Pollen

Standardized Bermuda Grass Pollen is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Cynodon Dactylon Pollen.

Product ID49288-0063_bb0c98b2-aaa8-49c4-887a-928e3937769c
NDC49288-0063
Product TypeHuman Prescription Drug
Proprietary NameStandardized Bermuda Grass Pollen
Generic NameStandardized Bermuda Grass Pollen
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1997-06-13
Marketing CategoryBLA / BLA
Application NumberBLA102226
Labeler NameAntigen Laboratories, Inc.
Substance NameCYNODON DACTYLON POLLEN
Active Ingredient Strength10000 [BAU]/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0063-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0063-3)
Marketing Start Date1997-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0063-3 [49288006303]

Standardized Bermuda Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102226
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0063-5 [49288006305]

Standardized Bermuda Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102226
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0063-4 [49288006304]

Standardized Bermuda Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102226
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0063-2 [49288006302]

Standardized Bermuda Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102226
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CYNODON DACTYLON POLLEN10000 [BAU]/mL

OpenFDA Data

SPL SET ID:c08f73ff-4f15-449c-9507-c422367f106b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 853027
  • 854054
  • 851873
  • 853047
  • 897496
  • 854162
  • 853278
  • 852157
  • Pharmacological Class

    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Standardized Pollen Allergenic Extract [EPC]

    NDC Crossover Matching brand name "Standardized Bermuda Grass Pollen" or generic name "Standardized Bermuda Grass Pollen"

    NDCBrand NameGeneric Name
    22840-0200Standardized Bermuda Grass PollenCynodon dactylon
    36987-2270Standardized Bermuda Grass PollenStandardized Bermuda Grass Pollen
    49288-0063Standardized Bermuda Grass PollenStandardized Bermuda Grass Pollen
    54575-084STANDARDIZED BERMUDA GRASS POLLENCynodon dactylon pollen

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