Enema
NDC 50730-2113
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Enema is a OTC MONOGRAPH NOT FINAL-approved product labeled by H And P Industries, Inc. Dba Triad Group. This medication may be used to relieve occasional constipation. It is supplied as a product. This product entry covers the primary NDC 50730-2113 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
50730-2113
Proprietary Name:
Enema
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
50730
Product Label ID:
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.
Marketing Timeline
Start Marketing Date: [9]
05-22-1996
End Marketing Date: [10]
05-31-2010
Listing Expiration Date: [11]
05-31-2010
Exclude Flag: [12]
D
Code Structure Chart
Product Details
What is NDC 50730-2113?
The NDC code 50730-2113 is assigned by the FDA to the product Enema. This pharmaceutical product is labeled by H And P Industries, Inc. Dba Triad Group and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50730-2113-0. 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?
This medication may be used to relieve occasional constipation. However, when treating constipation, you should use milder products (such as stool softeners, bulk-forming laxatives) whenever possible. Talk to your doctor or pharmacist about other treatment options. Your doctor may also prescribe this product (usually along with other products) to clean stool from the intestines before surgery or certain bowel procedures (such as colonoscopy, radiography). Use it only as directed by your doctor. Sodium phosphate is a saline laxative that is thought to work by increasing fluid in the small intestine. It usually causes a bowel movement after 1 to 5 minutes. Do not use this medication in children younger than 2 years of age.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- MINERAL OIL (UNII: T5L8T28FGP)
- MINERAL OIL (UNII: T5L8T28FGP) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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: 205121 - mineral oil 100 % Enema
- RxCUI: 205121 - mineral oil 1000 MG/ML Enema
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Product & Regulatory Definitions
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 End Marketing Date? 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.
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".
