NDC 0268-3060

Rye Grass, Perennial Standardized

Rye Grass, Perennial Standardized

Rye Grass, Perennial Standardized is a Percutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Allergenic Extract- Ryegrass, Perennial Lolium Perenne.

Product ID0268-3060_13f1ef62-876b-4a9f-90cd-bb7e307157e9
NDC0268-3060
Product TypeHuman Prescription Drug
Proprietary NameRye Grass, Perennial Standardized
Generic NameRye Grass, Perennial Standardized
Dosage FormSolution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103056
Labeler NameALK-Abello, Inc.
Substance NameALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0268-3060-06

5 mL in 1 VIAL, MULTI-DOSE (0268-3060-06)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-3060-06 [00268306006]

Rye Grass, Perennial Standardized SOLUTION
Marketing CategoryBLA
Application NumberBLA103056
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18
Marketing End Date2019-10-17

Drug Details

Active Ingredients

IngredientStrength
ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE10000 [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 "Rye Grass, Perennial Standardized" or generic name "Rye Grass, Perennial Standardized"

NDCBrand NameGeneric Name
0268-0289Rye Grass, Perennial StandardizedRye Grass, Perennial Standardized
0268-0290Rye Grass, Perennial StandardizedRye Grass, Perennial Standardized
0268-3059Rye Grass, Perennial StandardizedRye Grass, Perennial Standardized
0268-3060Rye Grass, Perennial StandardizedRye Grass, Perennial Standardized

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