NDC 54575-084

STANDARDIZED BERMUDA GRASS POLLEN

Cynodon Dactylon Pollen

STANDARDIZED BERMUDA 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 Cynodon Dactylon Pollen.

• Product ID: 54575-084_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
• NDC: 54575-084
• Product Type: Human Prescription Drug
• Proprietary Name: STANDARDIZED BERMUDA GRASS POLLEN
• Generic Name: Cynodon Dactylon Pollen
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-05-29
• Marketing Category: BLA / BLA
• Application Number: BLA101379
• Labeler Name: Allergy Laboratories, Inc.
• Substance Name: CYNODON DACTYLON POLLEN
• Active Ingredient Strength: 10000 [BAU]/mL
• Pharm Classes: Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 54575-084-02

2 mL in 1 VIAL, MULTI-DOSE (54575-084-02)

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

NDC SPL Data Element Entries

NDC 54575-084-10 [54575008410]

STANDARDIZED BERMUDA GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-084-30 [54575008430]

STANDARDIZED BERMUDA GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-084-50 [54575008450]

STANDARDIZED BERMUDA GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-084-02 [54575008402]

STANDARDIZED BERMUDA GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101379
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CYNODON DACTYLON POLLEN	10000 [BAU]/mL

Pharmacological Class

• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]

NDC Crossover Matching brand name "STANDARDIZED BERMUDA GRASS POLLEN" or generic name "Cynodon Dactylon Pollen"

NDC	Brand Name	Generic Name
22840-0200	Standardized Bermuda Grass Pollen	Cynodon dactylon
36987-2270	Standardized Bermuda Grass Pollen	Standardized Bermuda Grass Pollen
49288-0063	Standardized Bermuda Grass Pollen	Standardized Bermuda Grass Pollen
54575-084	STANDARDIZED BERMUDA GRASS POLLEN	Cynodon dactylon pollen
0268-0037	CENTER-AL - CYNODON DACTYLON POLLEN	CYNODON DACTYLON POLLEN
0268-0038	CENTER-AL - CYNODON DACTYLON POLLEN	CYNODON DACTYLON POLLEN