NDC 65044-0547

Standardized Grass Pollen, Bluegrass, Kentucky June

Standardized Grass Pollen, Bluegrass, Kentucky June

Standardized Grass Pollen, Bluegrass, Kentucky June is a Intradermal Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Poa Pratensis Pollen.

• Product ID: 65044-0547_76062435-a734-468d-88f3-d07042e05fea
• NDC: 65044-0547
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Grass Pollen, Bluegrass, Kentucky June
• Generic Name: Standardized Grass Pollen, Bluegrass, Kentucky June
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL
• Marketing Start Date: 1998-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA103873
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: POA PRATENSIS POLLEN
• Active Ingredient Strength: 100 [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: 2019-12-31

Packaging

NDC 65044-0547-5

5 mL in 1 VIAL (65044-0547-5)

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

NDC SPL Data Element Entries

NDC 65044-0547-5 [65044054705]

Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103873
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1998-01-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
POA PRATENSIS POLLEN	100 [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, Bluegrass, Kentucky June" or generic name "Standardized Grass Pollen, Bluegrass, Kentucky June"

NDC	Brand Name	Generic Name
65044-0545	Standardized Grass Pollen, Bluegrass, Kentucky June	Standardized Grass Pollen, Bluegrass, Kentucky June
65044-0546	Standardized Grass Pollen, Bluegrass, Kentucky June	Standardized Grass Pollen, Bluegrass, Kentucky June
65044-0547	Standardized Grass Pollen, Bluegrass, Kentucky June	Standardized Grass Pollen, Bluegrass, Kentucky June
65044-0548	Standardized Grass Pollen, Bluegrass, Kentucky June	Standardized Grass Pollen, Bluegrass, Kentucky June