NDC 71451-001 Pro-enema Single Saline Laxative

Sodium Phosphate,Dibasic And Sodium Phosphate,Monobasic,Unspecified Form Enema Rectal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
71451-001
Proprietary Name:
Pro-enema Single Saline Laxative
Non-Proprietary Name: [1]
Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic, Unspecified Form
Substance Name: [2]
Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic, Unspecified Form
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route(s): [4]
  • Rectal - Administration to the rectum.
  • Labeler Name: [5]
    Propharma Medical Supplies
    Labeler Code:
    71451
    FDA Application Number: [6]
    part334
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    06-06-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 71451-001-01

    Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 133 mL in 1 BOTTLE, WITH APPLICATOR

    Product Details

    What is NDC 71451-001?

    The NDC code 71451-001 is assigned by the FDA to the product Pro-enema Single Saline Laxative which is a human over the counter drug product labeled by Propharma Medical Supplies. The generic name of Pro-enema Single Saline Laxative is sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form. The product's dosage form is enema and is administered via rectal form. The product is distributed in a single package with assigned NDC code 71451-001-01 1 bottle, with applicator in 1 carton / 133 ml in 1 bottle, with applicator. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Pro-enema Single Saline Laxative?

    This product is used as Active ingredients (in each 118mL delivered dose)PurposeDibasic Sodium Phosphate 7 gSaline laxativeMonobasic Sodium Phosphate 19 gSaline laxative

    What are Pro-enema Single Saline Laxative Active Ingredients?

    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 Pro-enema Single Saline Laxative UNII Codes?

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

    • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
    • PHOSPHATE ION (UNII: NK08V8K8HR) (Active Moiety)
    • SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
    • SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

    Which are Pro-enema Single Saline Laxative Inactive Ingredients 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:

    What is the NDC to RxNorm Crosswalk for Pro-enema Single Saline Laxative?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema
    • RxCUI: 283100 - sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema
    • RxCUI: 283100 - sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema
    • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".