22840-9649 NDC - NEW STOCK FUNGI MIX (ACREMONIUM STRICTUM, ALTERNARIA ALTERNATA, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, BIPOLARIS SOROKINIANA, BOTRYTIS CINEREA, CANDIDA ALBICANS, CHAETOMIUM GLOBOSUM, CLADOSPORIUM SPHAEROSPERMUM, EPICOCCUM NIGRUM, GIBBERELLA FUJIKUROI, MUCOR PLUMBEUS, PENICILLIUM NOTATUM, PHOMA BETAE, RHIZOPUS STOLONIFER AND TRICHOPHYTON MENTAGROPHYTES)

Drug Information

Product NDC: 22840-9649
Proprietary Name: New Stock Fungi Mix
Non Proprietary Name: Acremonium strictum, Alternaria alternata, Aspergillus niger, Aureobasidium pullulans, Bipolaris sorokiniana, Botrytis cinerea, Candida albicans, Chaetomium globosum, Cladosporium sphaerospermum, Epicoccum nigrum, Gibberella fujikuroi, Mucor plumbeus, Penicillium notatum, Phoma betae, Rhizopus stolonifer and Trichophyton mentagrophytes
Active Ingredient(s): .00625 g/mL ACREMONIUM STRICTUM; .00625 g/mL ALTERNARIA ALTERNATA; .00625 g/mL ASPERGILLUS NIGER VAR. NIGER; .00625 g/mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS; .00625 g/mL BOTRYTIS CINEREA; .00625 g/mL CANDIDA ALBICANS; .00625 g/mL CHAETOMIUM GLOBOSUM; .00625 g/mL CLADOSPORIUM SPHAEROSPERMUM; .00625 g/mL COCHLIOBOLUS SATIVUS; .00625 g/mL EPICOCCUM NIGRUM; .00625 g/mL GIBBERELLA FUJIKUROI; .00625 g/mL MUCOR PLUMBEUS; .00625 g/mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; .00625 g/mL PLEOSPORA BETAE; .00625 g/mL RHIZOPUS STOLONIFER; .00625 g/mL TRICHOPHYTON MENTAGROPHYTES
Administration Route(s): INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Dosage Form(s): SOLUTION
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; 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]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal Proteins [CS]; Fungal 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 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]; 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 Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Greer Laboratories, Inc.
Product Type:	NON-STANDARDIZED ALLERGENIC
FDA Application Number:	BLA101833
Marketing Category:	BLA
Start Marketing Date:	9/15/1981

Package Information

No.	Package Code	Package Description	Billing Unit
1	22840-9649-2	10 mL in 1 VIAL, MULTI-DOSE (22840-9649-2)
2	22840-9649-4	50 mL in 1 VIAL, MULTI-DOSE (22840-9649-4)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	22840-9649	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	New Stock Fungi 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	Acremonium strictum, Alternaria alternata, Aspergillus niger, Aureobasidium pullulans, Bipolaris sorokiniana, Botrytis cinerea, Candida albicans, Chaetomium globosum, Cladosporium sphaerospermum, Epicoccum nigrum, Gibberella fujikuroi, Mucor plumbeus, Penicillium notatum, Phoma betae, Rhizopus stolonifer and Trichophyton mentagrophytes	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	SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/15/1981	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	BLA101833	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	Greer Laboratories, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACREMONIUM STRICTUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CANDIDA ALBICANS; CHAETOMIUM GLOBOSUM; CLADOSPORIUM SPHAEROSPERMUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; GIBBERELLA FUJIKUROI; MUCOR PLUMBEUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA BETAE; RHIZOPUS STOLONIFER; TRICHOPHYTON MENTAGROPHYTES	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	.00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625; .00625
ACTIVE INGRED UNIT	g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; 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], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal 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 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], 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 Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]

Drug Information

Labeler Information

Package Information

NDC Record

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