Rough Redroot Rough Redroot Solution
NDC 22840-5319

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 22840-5319?
  4. Rough Redroot Rough Redroot Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Rough Redroot Rough Redroot (amaranthus retroflexus) is a BLA-approved product labeled by Greer Laboratories, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a solution for intradermal; percutaneous; subcutaneous administration. This product entry covers the primary NDC 22840-5319 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
22840-5319
Proprietary Name:
Rough Redroot Rough Redroot
Non-Proprietary Name: [1]
Amaranthus Retroflexus
Substance Name: [2]
Amaranthus Retroflexus Pollen
NDC Directory Status:
Non-standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Intradermal - Administration within the dermis.
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Greer Laboratories, Inc.
Labeler Code:
22840
Product Label ID:
7b43b65a-bbfe-133f-e053-2991aa0a3395
FDA Application Number: [6]
BLA101833
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
09-15-1981
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 22840-5319?

The NDC code 22840-5319 is assigned by the FDA to the product Rough Redroot Rough Redroot. It is commonly known by its generic name, amaranthus retroflexus. This pharmaceutical product is labeled by Greer Laboratories, Inc. and is currently categorized as listed product. The medication is a solution administered via intradermal; percutaneous; subcutaneous route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 22840-5319-2, 22840-5319-4, 22840-5319-5. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION)

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (Active Moiety)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (Active Moiety)
  • AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O)
  • AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (Active Moiety)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (Active Moiety)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (Active Moiety)
  • ATRIPLEX LENTIFORMIS POLLEN (UNII: 86LWA5503I)
  • ATRIPLEX LENTIFORMIS POLLEN (UNII: 86LWA5503I) (Active Moiety)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (Active Moiety)
  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI)
  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (Active Moiety)
  • ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83)
  • ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (Active Moiety)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)
  • ALLENROLFEA OCCIDENTALIS POLLEN (UNII: 5W6JAI84OI)
  • ALLENROLFEA OCCIDENTALIS POLLEN (UNII: 5W6JAI84OI) (Active Moiety)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? 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.
What kind of product is this? 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".