22840-5453 NDC - RED OAK POLLEN (QUERCUS RUBRA)

Drug Information

Product NDC: 22840-5453
Proprietary Name: Red Oak Pollen
Non Proprietary Name: Quercus rubra
Active Ingredient(s): .05 g/mL QUERCUS RUBRA POLLEN
Administration Route(s): INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Dosage Form(s): 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:	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	22840-5453-2	10 mL in 1 VIAL, MULTI-DOSE (22840-5453-2)
2	22840-5453-3	30 mL in 1 VIAL, MULTI-DOSE (22840-5453-3)
3	22840-5453-4	50 mL in 1 VIAL, MULTI-DOSE (22840-5453-4)
4	22840-5453-5	5 mL in 1 BOTTLE, DROPPER (22840-5453-5)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	22840-5453	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAME	NON-STANDARDIZED ALLERGENIC	This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAME	Red Oak Pollen	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
NON PROPRIETARY NAME	Quercus rubra	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.
DOSAGE FORM NAME	SOLUTION	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.
ROUTE NAME	INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS	Name of Company corresponding to the labeler code segment of the Product NDC.
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	QUERCUS RUBRA 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
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]

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This page was last updated on: 12/6/2025

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