NDC 49643-443

River/Red Birch Pollen

Betula Nigra

River/Red Birch Pollen is a Cutaneous; Intradermal; Subcutaneous Injection in the Non-standardized Allergenic category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Betula Nigra Pollen.

• Product ID: 49643-443_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
• NDC: 49643-443
• Product Type: Non-standardized Allergenic
• Proprietary Name: River/Red Birch Pollen
• Generic Name: Betula Nigra
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1974-03-12
• Marketing Category: BLA / BLA
• Application Number: BLA102211
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: BETULA NIGRA POLLEN
• Active Ingredient Strength: 0 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49643-443-05

5 mL in 1 VIAL, MULTI-DOSE (49643-443-05)

• Marketing Start Date: 1974-03-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49643-443-30 [49643044330]

River/Red Birch Pollen INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-443-50 [49643044350]

River/Red Birch Pollen INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-443-10 [49643044310]

River/Red Birch Pollen INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-443-05 [49643044305]

River/Red Birch Pollen INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

Drug Details

Active Ingredients

Ingredient	Strength
BETULA NIGRA 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]

NDC Crossover Matching brand name "River/Red Birch Pollen" or generic name "Betula Nigra"

NDC	Brand Name	Generic Name
49643-443	River/Red Birch Pollen	Betula nigra
22840-1449	River Birch Pollen	Betula nigra
22840-1450	River Birch Pollen	Betula nigra
22840-1451	River Birch Pollen	Betula nigra
22840-1452	River Birch Pollen	Betula nigra
22840-4493	River Birch Pollen	Betula nigra
22840-5413	River Birch Pollen	Betula nigra