NDC 0268-0286

Redtop Grass, Standardized

Redtop Grass, Standardized

Redtop Grass, Standardized is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Agrostis Gigantea Pollen.

Product ID0268-0286_13f1ef62-876b-4a9f-90cd-bb7e307157e9
NDC0268-0286
Product TypeHuman Prescription Drug
Proprietary NameRedtop Grass, Standardized
Generic NameRedtop Grass, Standardized
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103055
Labeler NameALK-Abello, Inc.
Substance NameAGROSTIS GIGANTEA POLLEN
Active Ingredient Strength10000 [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 Through2018-12-31

Packaging

NDC 0268-0286-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0286-10)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0286-10 [00268028610]

Redtop Grass, Standardized INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103055
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

NDC 0268-0286-50 [00268028650]

Redtop Grass, Standardized INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103055
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18

Drug Details

Active Ingredients

IngredientStrength
AGROSTIS GIGANTEA POLLEN10000 [BAU]/mL

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 "Redtop Grass, Standardized" or generic name "Redtop Grass, Standardized"

NDCBrand NameGeneric Name
0268-0285Redtop Grass, StandardizedRedtop Grass, Standardized
0268-0286Redtop Grass, StandardizedRedtop Grass, Standardized
0268-3057Redtop Grass, StandardizedRedtop Grass, Standardized
0268-3058Redtop Grass, StandardizedRedtop Grass, Standardized

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