NDC 54575-107

STANDARDIZED TIMOTHY GRASS POLLEN

Phleum Pratense Pollen

STANDARDIZED TIMOTHY 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 Phleum Pratense Pollen.

• Product ID: 54575-107_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
• NDC: 54575-107
• Product Type: Human Prescription Drug
• Proprietary Name: STANDARDIZED TIMOTHY GRASS POLLEN
• Generic Name: Phleum Pratense Pollen
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-05-29
• Marketing Category: BLA / BLA
• Application Number: BLA101386
• Labeler Name: Allergy Laboratories, Inc.
• Substance Name: PHLEUM PRATENSE POLLEN
• Active Ingredient Strength: 100000 [BAU]/mL
• Pharm Classes: 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 54575-107-02

2 mL in 1 VIAL, MULTI-DOSE (54575-107-02)

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

NDC SPL Data Element Entries

NDC 54575-107-02 [54575010702]

STANDARDIZED TIMOTHY GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101386
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-107-50 [54575010750]

STANDARDIZED TIMOTHY GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101386
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-107-30 [54575010730]

STANDARDIZED TIMOTHY GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101386
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-107-10 [54575010710]

STANDARDIZED TIMOTHY GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101386
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PHLEUM PRATENSE POLLEN	100000 [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 TIMOTHY GRASS POLLEN" or generic name "Phleum Pratense Pollen"

NDC	Brand Name	Generic Name
36987-2401	Standardized Timothy Grass Pollen	Standardized Timothy Grass Pollen
36987-2402	Standardized Timothy Grass Pollen	Standardized Timothy Grass Pollen
49288-0575	Standardized Timothy Grass Pollen	Standardized Timothy Grass Pollen
54575-107	STANDARDIZED TIMOTHY GRASS POLLEN	Phleum pratense pollen
0268-0192	CENTER-AL - PHLEUM PRATENSE POLLEN	PHLEUM PRATENSE POLLEN
0268-0193	CENTER-AL - PHLEUM PRATENSE POLLEN	PHLEUM PRATENSE POLLEN