NDC 65044-1172

Pollens - Trees, Birch Mix

Birch Mix

Pollens - Trees, Birch Mix is a Percutaneous; Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Betula Papyrifera Pollen; Betula Pendula Pollen; Betula Nigra Pollen.

• Product ID: 65044-1172_542aadd7-a419-42a2-a51d-25c08491a652
• NDC: 65044-1172
• Product Type: Non-standardized Allergenic
• Proprietary Name: Pollens - Trees, Birch Mix
• Generic Name: Birch Mix
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1941-04-19
• Marketing Category: BLA / BLA
• Application Number: BLA103888
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN
• Active Ingredient Strength: 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL
• Pharm Classes: Non-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],Non-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: 2022-12-31

Packaging

NDC 65044-1172-2

10 mL in 1 VIAL (65044-1172-2)

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

NDC SPL Data Element Entries

NDC 65044-1172-2 [65044117202]

Pollens - Trees, Birch Mix INJECTION, SOLUTION

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

NDC 65044-1172-4 [65044117204]

Pollens - Trees, Birch Mix INJECTION, SOLUTION

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

NDC 65044-1172-3 [65044117203]

Pollens - Trees, Birch 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
BETULA PAPYRIFERA POLLEN	20000 [PNU]/mL

Pharmacological Class

• Non-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]
• Non-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 "Pollens - Trees, Birch Mix" or generic name "Birch Mix"

NDC	Brand Name	Generic Name
65044-1168	Pollens - Trees, Birch Mix	Birch Mix
65044-1169	Pollens - Trees, Birch Mix	Birch Mix
65044-1170	Pollens - Trees, Birch Mix	Birch Mix
65044-1171	Pollens - Trees, Birch Mix	Birch Mix
65044-1172	Pollens - Trees, Birch Mix	Birch Mix