NDC 54575-097

STANDARDIZED ORCHARD GRASS POLLEN

Dactylis Glomerata Pollen

STANDARDIZED ORCHARD 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 Dactylis Glomerata Pollen.

• Product ID: 54575-097_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c
• NDC: 54575-097
• Product Type: Human Prescription Drug
• Proprietary Name: STANDARDIZED ORCHARD GRASS POLLEN
• Generic Name: Dactylis Glomerata Pollen
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-05-29
• Marketing Category: BLA / BLA
• Application Number: BLA101382
• Labeler Name: Allergy Laboratories, Inc.
• Substance Name: DACTYLIS GLOMERATA 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 54575-097-10

10 mL in 1 VIAL, MULTI-DOSE (54575-097-10)

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

NDC SPL Data Element Entries

NDC 54575-097-30 [54575009730]

STANDARDIZED ORCHARD GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101382
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-097-10 [54575009710]

STANDARDIZED ORCHARD GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101382
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-097-02 [54575009702]

STANDARDIZED ORCHARD GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101382
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

NDC 54575-097-50 [54575009750]

STANDARDIZED ORCHARD GRASS POLLEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101382
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-05-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DACTYLIS GLOMERATA 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 ORCHARD GRASS POLLEN" or generic name "Dactylis Glomerata Pollen"

NDC	Brand Name	Generic Name
22840-0205	Standardized Orchard Grass Pollen	Dactylis glomerata
22840-0206	Standardized Orchard Grass Pollen	Dactylis glomerata
36987-2345	Standardized Orchard Grass Pollen	Standardized Orchard Grass Pollen
36987-2346	Standardized Orchard Grass Pollen	Standardized Orchard Grass Pollen
49288-0341	Standardized Orchard Grass Pollen	Standardized Orchard Grass Pollen
54575-097	STANDARDIZED ORCHARD GRASS POLLEN	Dactylis glomerata pollen
0268-0134	CENTER-AL - DACTYLIS GLOMERATA POLLEN	DACTYLIS GLOMERATA POLLEN