NDC 0268-0282

Orchard Grass, Standardized

Orchard Grass, Standardized

Orchard 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 Allergenic Extract- Orchard Grass Dactylis Glomerata.

• Product ID: 0268-0282_13f1ef62-876b-4a9f-90cd-bb7e307157e9
• NDC: 0268-0282
• Product Type: Human Prescription Drug
• Proprietary Name: Orchard Grass, Standardized
• Generic Name: Orchard Grass, Standardized
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1997-12-18
• Marketing Category: BLA / BLA
• Application Number: BLA103054
• Labeler Name: ALK-Abello, Inc.
• Substance Name: ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA
• 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0268-0282-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0282-10)

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

NDC SPL Data Element Entries

NDC 0268-0282-10 [00268028210]

Orchard Grass, Standardized INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103054
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1997-12-18

NDC 0268-0282-50 [00268028250]

Orchard Grass, Standardized INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103054
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1997-12-18

Drug Details

Active Ingredients

Ingredient	Strength
ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA	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 "Orchard Grass, Standardized" or generic name "Orchard Grass, Standardized"

NDC	Brand Name	Generic Name
0268-0281	Orchard Grass, Standardized	Orchard Grass, Standardized
0268-0282	Orchard Grass, Standardized	Orchard Grass, Standardized
0268-3055	Orchard Grass, Standardized	Orchard Grass, Standardized
0268-3056	Orchard Grass, Standardized	Orchard Grass, Standardized