NDC 0268-8024

BIRCH MIX

Betula Nigra Pollen And Betula Populifolia Pollen

BIRCH MIX is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Betula Nigra Pollen; Betula Populifolia Pollen.

• Product ID: 0268-8024_1bfa47a1-680f-4c15-9cd6-fd71c98f8c0c
• NDC: 0268-8024
• Product Type: Non-standardized Allergenic
• Proprietary Name: BIRCH MIX
• Generic Name: Betula Nigra Pollen And Betula Populifolia Pollen
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS
• Marketing Start Date: 1965-01-01
• Marketing Category: BLA / BLA
• Application Number: BLA103753
• Labeler Name: ALK-Abello, Inc.
• Substance Name: BETULA NIGRA POLLEN; BETULA POPULIFOLIA POLLEN
• Active Ingredient Strength: 0 g/mL; g/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]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0268-8024-10

10.5 mL in 1 VIAL (0268-8024-10)

• Marketing Start Date: 1998-02-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-8024-10 [00268802410]

BIRCH MIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103753
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-02-23

NDC 0268-8024-06 [00268802406]

BIRCH MIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103753
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1965-01-01

NDC 0268-8024-50 [00268802450]

BIRCH MIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103753
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-02-23

Drug Details

Active Ingredients

Ingredient	Strength
BETULA POPULIFOLIA POLLEN	.05 g/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]

NDC Crossover Matching brand name "BIRCH MIX" or generic name "Betula Nigra Pollen And Betula Populifolia Pollen"

NDC	Brand Name	Generic Name
0268-8024	BIRCH MIX	BETULA NIGRA POLLEN and BETULA POPULIFOLIA POLLEN
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