NDC 0268-0285

Redtop Grass, Standardized

Redtop Grass, Standardized

Redtop Grass, Standardized is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Agrostis Gigantea Pollen.

• Product ID: 0268-0285_13f1ef62-876b-4a9f-90cd-bb7e307157e9
• NDC: 0268-0285
• Product Type: Human Prescription Drug
• Proprietary Name: Redtop Grass, Standardized
• Generic Name: Redtop Grass, Standardized
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1997-12-18
• Marketing Category: BLA / BLA
• Application Number: BLA103055
• Labeler Name: ALK-Abello, Inc.
• Substance Name: AGROSTIS GIGANTEA POLLEN
• Active Ingredient Strength: 100000 [BAU]/mL
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Non-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: 2018-12-31

Packaging

NDC 0268-0285-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0285-10)

• Marketing Start Date: 1997-12-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-0285-50 [00268028550]

Redtop Grass, Standardized INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103055
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1997-12-18

NDC 0268-0285-10 [00268028510]

Redtop Grass, Standardized INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103055
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: ML
• Marketing Start Date: 1997-12-18

Drug Details

Active Ingredients

Ingredient	Strength
AGROSTIS GIGANTEA POLLEN	100000 [BAU]/mL

Pharmacological Class

• Standardized Pollen Allergenic Extract [EPC]
• Non-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 "Redtop Grass, Standardized" or generic name "Redtop Grass, Standardized"

NDC	Brand Name	Generic Name
0268-0285	Redtop Grass, Standardized	Redtop Grass, Standardized
0268-0286	Redtop Grass, Standardized	Redtop Grass, Standardized
0268-3057	Redtop Grass, Standardized	Redtop Grass, Standardized
0268-3058	Redtop Grass, Standardized	Redtop Grass, Standardized