NDC 49643-441

Spring Birch Pollen

Betula Fontinalis

Spring 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 Occidentalis Pollen.

• Product ID: 49643-441_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
• NDC: 49643-441
• Product Type: Non-standardized Allergenic
• Proprietary Name: Spring Birch Pollen
• Generic Name: Betula Fontinalis
• 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 OCCIDENTALIS POLLEN
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49643-441-05

5 mL in 1 VIAL, MULTI-DOSE (49643-441-05)

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

NDC SPL Data Element Entries

NDC 49643-441-30 [49643044130]

Spring Birch Pollen INJECTION

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

NDC 49643-441-10 [49643044110]

Spring Birch Pollen INJECTION

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

NDC 49643-441-05 [49643044105]

Spring Birch Pollen INJECTION

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

NDC 49643-441-50 [49643044150]

Spring 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 OCCIDENTALIS POLLEN	.05 g/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Spring Birch Pollen" or generic name "Betula Fontinalis"

NDC	Brand Name	Generic Name
22840-1454	Spring Birch Pollen	Betula occidentalis
22840-1455	Spring Birch Pollen	Betula occidentalis
22840-1456	Spring Birch Pollen	Betula occidentalis
22840-4436	Spring Birch Pollen	Betula occidentalis
22840-5414	Spring Birch Pollen	Betula occidentalis
49643-441	Spring Birch Pollen	Betula fontinalis