NDC 54575-099

STANDARDIZED REDTOP GRASS POLLEN

Agrostis Alba Pollen

STANDARDIZED REDTOP 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 Agrostis Gigantea Pollen.

• Product ID: 54575-099_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
• NDC: 54575-099
• Product Type: Human Prescription Drug
• Proprietary Name: STANDARDIZED REDTOP GRASS POLLEN
• Generic Name: Agrostis Alba Pollen
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-05-29
• Marketing Category: BLA / BLA
• Application Number: BLA101383
• Labeler Name: Allergy Laboratories, Inc.
• Substance Name: AGROSTIS GIGANTEA POLLEN
• Active Ingredient Strength: 100000 [BAU]/mL
• Pharm Classes: 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 Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 54575-099-50

50 mL in 1 VIAL, MULTI-DOSE (54575-099-50)

• Marketing Start Date: 1997-05-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54575-099-50 [54575009950]

STANDARDIZED REDTOP GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101383
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-099-02 [54575009902]

STANDARDIZED REDTOP GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101383
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-099-30 [54575009930]

STANDARDIZED REDTOP GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101383
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-099-10 [54575009910]

STANDARDIZED REDTOP GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101383
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AGROSTIS GIGANTEA POLLEN	100000 [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 "STANDARDIZED REDTOP GRASS POLLEN" or generic name "Agrostis Alba Pollen"

NDC	Brand Name	Generic Name
36987-2363	Standardized Redtop Grass Pollen	Standardized Redtop Grass Pollen
36987-2364	Standardized Redtop Grass Pollen	Standardized Redtop Grass Pollen
49288-0451	Standardized Redtop Grass Pollen	Standardized Redtop Grass Pollen
54575-099	STANDARDIZED REDTOP GRASS POLLEN	Agrostis alba pollen