NDC 65044-0857

Pollens - Grasses, Southern Grass Mix

Pollens - Grasses, Southern Grass Mix

Pollens - Grasses, Southern Grass Mix is a Percutaneous Injection, Solution in the Non-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; Sorghum Halepense Pollen; Cynodon Dactylon Pollen.

• Product ID: 65044-0857_7bd74194-f6a5-47fd-85bc-abc20faa6b2d
• NDC: 65044-0857
• Product Type: Non-standardized Allergenic
• Proprietary Name: Pollens - Grasses, Southern Grass Mix
• Generic Name: Pollens - Grasses, Southern Grass Mix
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS
• Marketing Start Date: 1941-04-19
• Marketing Category: BLA / BLA
• Application Number: BLA103888
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN
• Active Ingredient Strength: 10000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65044-0857-1

5 mL in 1 VIAL (65044-0857-1)

• Marketing Start Date: 1941-04-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65044-0857-1 [65044085701]

Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103888
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1941-04-19

Drug Details

Active Ingredients

Ingredient	Strength
POA PRATENSIS POLLEN	10000 [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]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• 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 "Pollens - Grasses, Southern Grass Mix" or generic name "Pollens - Grasses, Southern Grass Mix"

NDC	Brand Name	Generic Name
65044-0854	Pollens - Grasses, Southern Grass Mix	Pollens - Grasses, Southern Grass Mix
65044-0855	Pollens - Grasses, Southern Grass Mix	Pollens - Grasses, Southern Grass Mix
65044-0856	Pollens - Grasses, Southern Grass Mix	Pollens - Grasses, Southern Grass Mix
65044-0857	Pollens - Grasses, Southern Grass Mix	Pollens - Grasses, Southern Grass Mix