0268-8000 NDC - 10 TREE MIX (ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN)

Drug Information

Product NDC: 0268-8000
Proprietary Name: 10 TREE MIX
Non Proprietary Name: ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN and ULMUS AMERICANA POLLEN
Active Ingredient(s): .05 g/mL ACER NEGUNDO POLLEN; .05 g/mL BETULA NIGRA POLLEN; .05 g/mL BLACK WALNUT; .05 g/mL CARYA OVATA POLLEN; .05 g/mL FRAXINUS AMERICANA POLLEN; .05 g/mL PLATANUS OCCIDENTALIS POLLEN; .05 g/mL POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; .05 g/mL QUERCUS RUBRA POLLEN; .05 g/mL SALIX NIGRA POLLEN; .05 g/mL ULMUS AMERICANA POLLEN
Administration Route(s): SUBCUTANEOUS
Dosage Form(s): INJECTION, SOLUTION
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Nut Proteins [EXT]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	ALK-Abello, Inc.
Product Type:	NON-STANDARDIZED ALLERGENIC
FDA Application Number:	BLA103753
Marketing Category:	BLA
Start Marketing Date:	2/23/1998

Package Information

No.	Package Code	Package Description	Billing Unit
1	0268-8000-10	10.5 mL in 1 VIAL (0268-8000-10)
2	0268-8000-50	53 mL in 1 VIAL (0268-8000-50)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0268-8000	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	NON-STANDARDIZED ALLERGENIC	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	10 TREE MIX	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN and ULMUS AMERICANA POLLEN	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	INJECTION, SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	SUBCUTANEOUS	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	2/23/1998	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	BLA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	BLA103753	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	ALK-Abello, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; BLACK WALNUT; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	.05; .05; .05; .05; .05; .05; .05; .05; .05; .05
ACTIVE INGRED UNIT	g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
PHARM CLASSES	Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Nut Proteins [EXT], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]

0268-8000 NDC - 10 TREE MIX (ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN)

Drug Information

Labeler Information

Package Information

NDC Record

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