NDC 65044-3021

Food - Plant Source, Apple Malus sp.

Apple Malus Sp.

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

• Product ID: 65044-3021_a75e0709-e1c2-49ca-8c13-7e21d455d883
• NDC: 65044-3021
• Product Type: Non-standardized Allergenic
• Proprietary Name: Food - Plant Source, Apple Malus sp.
• Generic Name: Apple Malus Sp.
• 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: APPLE
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65044-3021-1

5 mL in 1 VIAL (65044-3021-1)

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

NDC SPL Data Element Entries

NDC 65044-3021-1 [65044302101]

Food - Plant Source, Apple Malus sp. INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103888
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1941-04-19
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
APPLE	.1 g/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Food - Plant Source, Apple Malus sp." or generic name "Apple Malus Sp."

NDC	Brand Name	Generic Name
65044-3020	Food - Plant Source, Apple Malus sp.	Apple Malus sp.
65044-3021	Food - Plant Source, Apple Malus sp.	Apple Malus sp.