NDC 49643-020

Orris Root

Orris Root

Orris Root is a Cutaneous; Intradermal; Subcutaneous Injection in the Non-standardized Allergenic category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Iris Germanica Var. Florentina Root.

• Product ID: 49643-020_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
• NDC: 49643-020
• Product Type: Non-standardized Allergenic
• Proprietary Name: Orris Root
• Generic Name: Orris Root
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1974-03-12
• Marketing Category: BLA / BLA
• Application Number: BLA102211
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: IRIS GERMANICA VAR. FLORENTINA ROOT
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49643-020-05

5 mL in 1 VIAL, MULTI-DOSE (49643-020-05)

• Marketing Start Date: 1974-03-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49643-020-30 [49643002030]

Orris Root INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-020-50 [49643002050]

Orris Root INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-020-05 [49643002005]

Orris Root INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

NDC 49643-020-10 [49643002010]

Orris Root INJECTION

• Marketing Category: BLA
• Application Number: BLA102211
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1974-03-12

Drug Details

Active Ingredients

Ingredient	Strength
IRIS GERMANICA VAR. FLORENTINA ROOT	.1 g/mL

Pharmacological Class

• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Allergens [CS]
• Plant Proteins [CS]

NDC Crossover Matching brand name "Orris Root" or generic name "Orris Root"

NDC	Brand Name	Generic Name
22840-1530	Orris Root	Iris germanica
22840-1531	Orris Root	Iris germanica
22840-5515	Orris Root	Iris germanica
36987-2234	Orris Root	Orris Root
36987-2235	Orris Root	Orris Root
36987-2236	Orris Root	Orris Root
36987-2237	Orris Root	Orris Root
49288-0343	Orris Root	Orris Root
49288-0344	Orris Root	Orris Root
49643-020	Orris Root	Orris Root
54575-272	ORRIS ROOT	iris germanica var. florentina root