65044-2362 NDC - POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI (RUSSIAN THISTLE SALSOLA KALI)

Drug Information

Product NDC: 65044-2362
Proprietary Name: Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali
Non Proprietary Name: Russian Thistle Salsola kali
Active Ingredient(s): .05 g/mL SALSOLA KALI POLLEN
Administration Route(s): PERCUTANEOUS; SUBCUTANEOUS
Dosage Form(s): INJECTION, SOLUTION
Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Pollen Allergenic Extract [EPC]; Pollen [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Jubilant HollisterStier LLC
Product Type:	NON-STANDARDIZED ALLERGENIC
FDA Application Number:	BLA103888
Marketing Category:	BLA
Start Marketing Date:	4/19/1941

Package Information

No.	Package Code	Package Description
1	65044-2362-2	10 mL in 1 VIAL (65044-2362-2)
2	65044-2362-3	30 mL in 1 VIAL (65044-2362-3)
3	65044-2362-4	50 mL in 1 VIAL (65044-2362-4)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	65044-2362	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	Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali	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	Russian Thistle Salsola kali	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	PERCUTANEOUS; SUBCUTANEOUS	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.
START MARKETING DATE	4/19/1941	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.
MARKETING CATEGORY NAME	BLA	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	BLA103888	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAME	Jubilant HollisterStier LLC	The translation of the dosage form Code submitted by the firm.
SUBSTANCE NAME	SALSOLA KALI POLLEN	The translation of the route code submitted by the firm, indicating route of administration.
ACTIVE NUMERATOR STRENGTH	.05
ACTIVE INGRED UNIT	g/mL
PHARM CLASSES	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]

65044-2362 NDC - POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI (RUSSIAN THISTLE SALSOLA KALI)

Drug Information

Labeler Information

Package Information

NDC Record

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