NDC 65044-0537

Standardized Grass Pollen, Bermuda Grass

Standardized Grass Pollen, Bermuda Grass

Standardized Grass Pollen, Bermuda Grass is a Percutaneous; Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Cynodon Dactylon Pollen.

• Product ID: 65044-0537_0cdf6656-6263-450e-a312-5cb125444591
• NDC: 65044-0537
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Grass Pollen, Bermuda Grass
• Generic Name: Standardized Grass Pollen, Bermuda Grass
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1998-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA103872
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: CYNODON DACTYLON POLLEN
• Active Ingredient Strength: 10000 [BAU]/mL
• Pharm Classes: Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65044-0537-1

5 mL in 1 VIAL (65044-0537-1)

• Marketing Start Date: 1998-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65044-0537-4 [65044053704]

Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103872
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0537-2 [65044053702]

Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103872
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0537-3 [65044053703]

Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103872
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0537-1 [65044053701]

Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103872
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

Drug Details

Active Ingredients

Ingredient	Strength
CYNODON DACTYLON POLLEN	10000 [BAU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Standardized Grass Pollen, Bermuda Grass" or generic name "Standardized Grass Pollen, Bermuda Grass"

NDC	Brand Name	Generic Name
65044-0537	Standardized Grass Pollen, Bermuda Grass	Standardized Grass Pollen, Bermuda Grass
65044-0538	Standardized Grass Pollen, Bermuda Grass	Standardized Grass Pollen, Bermuda Grass