NDC 49643-364

Rough Marshelder Pollen

Iva Ciliata

Rough Marshelder Pollen 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 Iva Annua Pollen.

• Product ID: 49643-364_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
• NDC: 49643-364
• Product Type: Non-standardized Allergenic
• Proprietary Name: Rough Marshelder Pollen
• Generic Name: Iva Ciliata
• 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: IVA ANNUA POLLEN
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49643-364-05

5 mL in 1 VIAL, MULTI-DOSE (49643-364-05)

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

NDC SPL Data Element Entries

NDC 49643-364-30 [49643036430]

Rough Marshelder Pollen INJECTION

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

NDC 49643-364-50 [49643036450]

Rough Marshelder Pollen INJECTION

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

NDC 49643-364-05 [49643036405]

Rough Marshelder Pollen INJECTION

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

NDC 49643-364-10 [49643036410]

Rough Marshelder Pollen INJECTION

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

Drug Details

Active Ingredients

Ingredient	Strength
IVA ANNUA POLLEN	.05 g/mL

Pharmacological Class

• 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 "Rough Marshelder Pollen" or generic name "Iva Ciliata"

NDC	Brand Name	Generic Name
49643-364	Rough Marshelder Pollen	Iva ciliata
54575-135	ROUGH MARSHELDER POLLEN	iva annua var. annua pollen