NDC 0268-1072

BETULA LENTA POLLEN

Birch White

BETULA LENTA POLLEN is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Betula Lenta Pollen.

• Product ID: 0268-1072_152accc2-8563-4b11-9c7c-f61b002b30f8
• NDC: 0268-1072
• Product Type: Non-standardized Allergenic
• Proprietary Name: BETULA LENTA POLLEN
• Generic Name: Birch White
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1965-01-01
• Marketing End Date: 2021-11-30
• Marketing Category: BLA / BLA
• Application Number: BLA103753
• Labeler Name: ALK-Abello, Inc.
• Substance Name: BETULA LENTA POLLEN
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N

Packaging

NDC 0268-1072-50

50 mL in 1 VIAL, MULTI-DOSE (0268-1072-50)

• Marketing Start Date: 1965-01-01
• Marketing End Date: 2021-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-1072-50 [00268107250]

BETULA LENTA POLLEN INJECTION, SOLUTION

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

Drug Details

Active Ingredients

Ingredient	Strength
BETULA LENTA POLLEN	.0005 g/mL

Pharmacological Class

• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "BETULA LENTA POLLEN" or generic name "Birch White"

NDC	Brand Name	Generic Name
0268-1056	BETULA LENTA POLLEN	Birch Black
0268-1057	BETULA LENTA POLLEN	Birch Black
0268-1058	BETULA LENTA POLLEN	Birch Black
0268-1059	BETULA LENTA POLLEN	Birch Black
0268-1069	BETULA LENTA POLLEN	Birch White
0268-1070	BETULA LENTA POLLEN	Birch White
0268-1071	BETULA LENTA POLLEN	Birch White
0268-1072	BETULA LENTA POLLEN	Birch White
0268-1073	BETULA LENTA POLLEN	Birch White
0268-6608	BETULA LENTA POLLEN	Black Birch
0268-6610	BETULA LENTA POLLEN	White Birch
0268-6686	BETULA LENTA POLLEN	Black Birch
0268-6688	BETULA LENTA POLLEN	White Birch
0268-6772	BETULA LENTA POLLEN	White Pine
0268-0041	CENTER-AL - BETULA LENTA POLLEN	BETULA LENTA POLLEN