NDC 65044-0831

Standardized Grass Pollen, Timothy

Standardized Grass Pollen, Timothy

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

• Product ID: 65044-0831_0cdf6656-6263-450e-a312-5cb125444591
• NDC: 65044-0831
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Grass Pollen, Timothy
• Generic Name: Standardized Grass Pollen, Timothy
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS; SUBCUTANEOUS
• Marketing Start Date: 1998-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA103879
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: PHLEUM PRATENSE POLLEN
• Active Ingredient Strength: 10000 [BAU]/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: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65044-0831-1

5 mL in 1 VIAL (65044-0831-1)

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

NDC SPL Data Element Entries

NDC 65044-0831-4 [65044083104]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103879
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0831-2 [65044083102]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103879
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0831-1 [65044083101]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103879
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

NDC 65044-0831-3 [65044083103]

Standardized Grass Pollen, Timothy INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103879
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15

Drug Details

Active Ingredients

Ingredient	Strength
PHLEUM PRATENSE POLLEN	10000 [BAU]/mL

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 Grass Pollen, Timothy" or generic name "Standardized Grass Pollen, Timothy"

NDC	Brand Name	Generic Name
65044-0831	Standardized Grass Pollen, Timothy	Standardized Grass Pollen, Timothy
65044-0832	Standardized Grass Pollen, Timothy	Standardized Grass Pollen, Timothy
65044-0833	Standardized Grass Pollen, Timothy	Standardized Grass Pollen, Timothy
65044-0834	Standardized Grass Pollen, Timothy	Standardized Grass Pollen, Timothy