NDC 49288-0448

Standardized Short Ragweed Pollen

Standardized Short Ragweed Pollen

Standardized Short Ragweed Pollen is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Ambrosia Artemisiifolia Pollen.

• Product ID: 49288-0448_3a632396-c97c-4b7f-8eef-8908cf591385
• NDC: 49288-0448
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Short Ragweed Pollen
• Generic Name: Standardized Short Ragweed Pollen
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1983-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA102232
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: AMBROSIA ARTEMISIIFOLIA POLLEN
• Active Ingredient Strength: 100000 [AU]/mL
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0448-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0448-3)

• Marketing Start Date: 1983-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0448-2 [49288044802]

Standardized Short Ragweed Pollen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102232
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1983-01-15
• Inactivation Date: 2019-10-21

NDC 49288-0448-3 [49288044803]

Standardized Short Ragweed Pollen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102232
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1983-01-15
• Inactivation Date: 2019-10-21

NDC 49288-0448-4 [49288044804]

Standardized Short Ragweed Pollen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102232
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1983-01-15
• Inactivation Date: 2019-10-21

NDC 49288-0448-5 [49288044805]

Standardized Short Ragweed Pollen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102232
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1983-01-15
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
AMBROSIA ARTEMISIIFOLIA POLLEN	100000 [AU]/mL

OpenFDA Data

• SPL SET ID: 4e6f2764-63a7-4d99-82c6-3b319a246296
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • K20Y81ACO3
• RxNorm Concept Unique ID - RxCUI:
  • 896144

Pharmacological Class

• 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 "Standardized Short Ragweed Pollen" or generic name "Standardized Short Ragweed Pollen"

NDC	Brand Name	Generic Name
49288-0448	Standardized Short Ragweed Pollen	Standardized Short Ragweed Pollen
54575-147	STANDARDIZED SHORT RAGWEED POLLEN	ambrosia artemisiifolia pollen