NDC 49643-379

Standardized Perennial Rye Grass

Lolium Perenne

Standardized Perennial Rye Grass is a Cutaneous; Intradermal; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Lolium Perenne Pollen.

Product ID49643-379_92edfda3-37dd-daa1-e053-2a95a90a5c1f
NDC49643-379
Product TypeHuman Prescription Drug
Proprietary NameStandardized Perennial Rye Grass
Generic NameLolium Perenne
Dosage FormInjection
Route of AdministrationCUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Marketing Start Date1996-12-02
Marketing CategoryBLA / BLA
Application NumberBLA102219
Labeler NameAllermed Laboratories, Inc.
Substance NameLOLIUM PERENNE POLLEN
Active Ingredient Strength100000 [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 Through2020-12-31

Packaging

NDC 49643-379-05

5 mL in 1 VIAL, MULTI-DOSE (49643-379-05)
Marketing Start Date1996-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49643-379-10 [49643037910]

Standardized Perennial Rye Grass INJECTION
Marketing CategoryBLA
Application NumberBLA102219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-02

NDC 49643-379-50 [49643037950]

Standardized Perennial Rye Grass INJECTION
Marketing CategoryBLA
Application NumberBLA102219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-02

NDC 49643-379-05 [49643037905]

Standardized Perennial Rye Grass INJECTION
Marketing CategoryBLA
Application NumberBLA102219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-02

NDC 49643-379-30 [49643037930]

Standardized Perennial Rye Grass INJECTION
Marketing CategoryBLA
Application NumberBLA102219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-12-02

Drug Details

Active Ingredients

IngredientStrength
LOLIUM PERENNE POLLEN100000 [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 Perennial Rye Grass" or generic name "Lolium Perenne"

NDCBrand NameGeneric Name
49643-379Standardized Perennial Rye GrassLolium perenne
22840-0209Standardized Perennial Ryegrass PollenLolium perenne
22840-0210Standardized Perennial Ryegrass PollenLolium perenne

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