NDC 65044-0846

Standardized Grass Pollen, Grass Mix 5

Standardized Grass Pollen, Grass Mix 5

Standardized Grass Pollen, Grass Mix 5 is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen; Dactylis Glomerata Pollen; Agrostis Gigantea Pollen; Phleum Pratense Pollen; Anthoxanthum Odoratum Pollen.

• Product ID: 65044-0846_d35f56c5-a667-4175-83dc-963235f74ab6
• NDC: 65044-0846
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Grass Pollen, Grass Mix 5
• Generic Name: Standardized Grass Pollen, Grass Mix 5
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1998-01-05
• Marketing Category: BLA / BLA
• Application Number: BLA103873
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN
• Active Ingredient Strength: 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65044-0846-2

10 mL in 1 VIAL (65044-0846-2)

• Marketing Start Date: 1998-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65044-0846-4 [65044084604]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103873
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-05
• Marketing End Date: 2019-11-21

NDC 65044-0846-2 [65044084602]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103873
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-05
• Marketing End Date: 2019-11-21

NDC 65044-0846-1 [65044084601]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103873
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-05
• Marketing End Date: 2019-11-21

NDC 65044-0846-3 [65044084603]

Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103873
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-05
• Marketing End Date: 2019-11-21

Drug Details

Active Ingredients

Ingredient	Strength
POA PRATENSIS POLLEN	20000 [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]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• 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]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• 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 Grass Pollen, Grass Mix 5" or generic name "Standardized Grass Pollen, Grass Mix 5"

NDC	Brand Name	Generic Name
65044-0845	Standardized Grass Pollen, Grass Mix 5	Standardized Grass Pollen, Grass Mix 5
65044-0846	Standardized Grass Pollen, Grass Mix 5	Standardized Grass Pollen, Grass Mix 5
65044-0847	Standardized Grass Pollen, Grass Mix 5	Standardized Grass Pollen, Grass Mix 5
65044-0848	Standardized Grass Pollen, Grass Mix 5	Standardized Grass Pollen, Grass Mix 5