NDC 65044-3429

Food - Plant Source, Orange Citrus sinensis

Orange Citrus Sinensis

Food - Plant Source, Orange Citrus sinensis is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Orange.

• Product ID: 65044-3429_5c97b4db-dd8b-48ca-8321-82ebf95159ee
• NDC: 65044-3429
• Product Type: Non-standardized Allergenic
• Proprietary Name: Food - Plant Source, Orange Citrus sinensis
• Generic Name: Orange Citrus Sinensis
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS
• Marketing Start Date: 1941-04-19
• Marketing Category: BLA / BLA
• Application Number: BLA103888
• Labeler Name: Jubilant HollisterStier LLC
• Substance Name: ORANGE
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65044-3429-1

5 mL in 1 VIAL (65044-3429-1)

• Marketing Start Date: 1941-04-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65044-3429-1 [65044342901]

Food - Plant Source, Orange Citrus sinensis INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103888
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1941-04-19

Drug Details

Active Ingredients

Ingredient	Strength
ORANGE	.1 g/mL

Pharmacological Class

• Non-Standardized Food Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Fruit Proteins [EXT]

NDC Crossover Matching brand name "Food - Plant Source, Orange Citrus sinensis" or generic name "Orange Citrus Sinensis"

NDC	Brand Name	Generic Name
65044-3428	Food - Plant Source, Orange Citrus sinensis	Orange Citrus sinensis
65044-3429	Food - Plant Source, Orange Citrus sinensis	Orange Citrus sinensis