NDC 54575-106

STANDARDIZED SWEET VERNAL GRASS POLLEN

Anthoxanthum Odoratum Pollen

STANDARDIZED SWEET VERNAL GRASS POLLEN is a Percutaneous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Allergy Laboratories, Inc.. The primary component is Anthoxanthum Odoratum Pollen.

Product ID54575-106_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
NDC54575-106
Product TypeHuman Prescription Drug
Proprietary NameSTANDARDIZED SWEET VERNAL GRASS POLLEN
Generic NameAnthoxanthum Odoratum Pollen
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1997-05-29
Marketing CategoryBLA / BLA
Application NumberBLA101385
Labeler NameAllergy Laboratories, Inc.
Substance NameANTHOXANTHUM ODORATUM 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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 54575-106-02

2 mL in 1 VIAL, MULTI-DOSE (54575-106-02)
Marketing Start Date1997-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54575-106-02 [54575010602]

STANDARDIZED SWEET VERNAL GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-05-29
Inactivation Date2020-01-31

NDC 54575-106-50 [54575010650]

STANDARDIZED SWEET VERNAL GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-05-29
Inactivation Date2020-01-31

NDC 54575-106-30 [54575010630]

STANDARDIZED SWEET VERNAL GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-05-29
Inactivation Date2020-01-31

NDC 54575-106-10 [54575010610]

STANDARDIZED SWEET VERNAL GRASS POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA101385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-05-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ANTHOXANTHUM ODORATUM 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 SWEET VERNAL GRASS POLLEN" or generic name "Anthoxanthum Odoratum Pollen"

NDCBrand NameGeneric Name
22840-0211Standardized Sweet Vernal Grass PollenAnthoxanthum odoratum
22840-0212Standardized Sweet Vernal Grass PollenAnthoxanthum odoratum
36987-2399Standardized Sweet Vernal Grass PollenStandardized Sweet Vernal Grass Pollen
36987-2400Standardized Sweet Vernal Grass PollenStandardized Sweet Vernal Grass Pollen
49288-0492Standardized Sweet Vernal Grass PollenStandardized Sweet Vernal Grass Pollen
54575-106STANDARDIZED SWEET VERNAL GRASS POLLENAnthoxanthum odoratum pollen

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