NDC 49288-0451

Standardized Redtop Grass Pollen

Standardized Redtop Grass Pollen

Standardized Redtop 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 Agrostis Gigantea Pollen.

Product ID49288-0451_bb0c98b2-aaa8-49c4-887a-928e3937769c
NDC49288-0451
Product TypeHuman Prescription Drug
Proprietary NameStandardized Redtop Grass Pollen
Generic NameStandardized Redtop Grass Pollen
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1997-06-13
Marketing CategoryBLA / BLA
Application NumberBLA102229
Labeler NameAntigen Laboratories, Inc.
Substance NameAGROSTIS GIGANTEA POLLEN
Active Ingredient Strength100000 [BAU]/mL
Pharm ClassesStandardized 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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0451-4

30 mL in 1 VIAL, MULTI-DOSE (49288-0451-4)
Marketing Start Date1997-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0451-2 [49288045102]

Standardized Redtop Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102229
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0451-4 [49288045104]

Standardized Redtop Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102229
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0451-5 [49288045105]

Standardized Redtop Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102229
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

NDC 49288-0451-3 [49288045103]

Standardized Redtop Grass Pollen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102229
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-06-13
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
AGROSTIS GIGANTEA POLLEN100000 [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

    • 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]

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

    NDCBrand NameGeneric Name
    36987-2363Standardized Redtop Grass PollenStandardized Redtop Grass Pollen
    36987-2364Standardized Redtop Grass PollenStandardized Redtop Grass Pollen
    49288-0451Standardized Redtop Grass PollenStandardized Redtop Grass Pollen
    54575-099STANDARDIZED REDTOP GRASS POLLENAgrostis alba pollen

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