NDC 49643-315-50 HUMAN PRESCRIPTION DRUG

Drug Status:  Active

Proprietary Name: Short Ragweed

Drug Overview

The NDC Code 49643-315-50 is assigned to “Short Ragweed ” (also known as: “Ambrosia Artemisiifolia”), a human prescription drug labeled by “Allermed Laboratories, Inc.”. The product's dosage form is injection, and is administered via cutaneous; intradermal; subcutaneous form.

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Drug Information
NDC Package Code	49643-315-50
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	49643-315
	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.
11 Digit NDC Code	49643-0315-50
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Short Ragweed
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Ambrosia Artemisiifolia
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Allermed Laboratories, Inc.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	INGREDIENTS - Allergenic extract of short ragweed pollen is a clear, amber-colored solution prepared from the dry, defatted pollen of Ambrosia elatior. The extract contains the water extractables of the pollen, 0.25% sodium chloride, 0.125% sodium bicarbonate, 0.5% phenol and 50% glycerol by volume. Extract of mixed short-giant ragweed has the same appearance as short ragweed pollen extract and contains the same chemical ingredients. It is prepared from equal gram weights of the pollens of Ambrosia elatior and Ambrosia trifida. STANDARDIZATION - The potency of ragweed pollen extract is based on antigen E, a protein component which is believed to be the most important allergen of short ragweed pollen. Extracts of short ragweed pollen sold in the U.S. must have a minimum antigen E content of 67.5 units per ml for a 1:20 w/v concentrate. Extracts of mixed short-giant ragweed must have a minimum antigen E content of 33.75 units/ml for a 1:20 w/v concentrate. The importance of antigen E in ragweed allergy is based on the following observations: : 1 In vitro studies with antigen E have shown that it is capable of causing histamine release from peripheral leukocytes of ragweed sensitive persons 1. , 2 The antigen E content of short ragweed pollen extract has been found to correlate with extract potency when measured by skin test response in persons allergic to short ragweed pollen 2. , 3 Immunotherapy with antigen E has been shown to be comparably effective to whole short ragweed pollen extract in reducing symptoms related to ragweed pollen exposure 3. .
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	Studies have shown that properly performed an interpreted skin tests with ragweed pollen extract are useful in the diagnosis of allergy to ragweed pollen 7, 8, 20, 21. Immunotherapy with the appropriate dosage of short ragweed pollen extract is effective in reducing symptoms of hay fever and asthma resulting from exposure to short ragweed pollen (9, 10, 11), and it is believed to be effective with extract of giant ragweed, although carefully controlled studies are unavailable. However, clinical observations and known cross reactivity between short and giant ragweed pollens have led to the practice of using a mixture of the two species for skin testing and treatment 22, 23, 24, 25, 26, 27. This form of treatment is recommended for patients who cannot avoid exposure to pollen and who do not obtain satisfactory relief of symptoms from other medications, such as antihistamines. Immunologic changes resulting from treatment with short ragweed pollen extract are believed to include: : 1 The induction of specific anti-ragweed IgG antibodies commonly referred to as "blocking antibodies" 12, 13. , 2 A decrease in the elevation of ragweed specific IgE during and immediately following the ragweed pollen season 14. , 3 A reduction of circulating anti-ragweed IgE after long-term immunotherapy 15. , 4 A decrease in skin reactivity to the extract 16 and a decrease in leukocyte sensitivity to histamine release 17 after long-term immunotherapy. .
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	INJECTION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	ALLERGENS [CS], CELL-MEDIATED IMMUNITY [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED IGG PRODUCTION [PE], POLLEN [CS], STANDARDIZED POLLEN ALLERGENIC EXTRACT [EPC]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	AMBROSIA ARTEMISIIFOLIA POLLEN - 1 g/10mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	49643-315-50
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	50 ML IN 1 VIAL, MULTI-DOSE (49643-315-50)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	19820322
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package 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. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	49643-315
	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.
Application Number	BLA103113
	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.
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.
Listing Record Certified Through	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	19820322
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	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.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2025-06-05
	The date that a record was last updated or changed.