NDC 58607-700 Polyethylene Glycol 3350 Nf Pegylax

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 58607-700 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
58607-700
Proprietary Name:
Polyethylene Glycol 3350 Nf Pegylax
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
58607
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
12-16-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 58607-700?

The NDC code 58607-700 is assigned by the FDA to the product Polyethylene Glycol 3350 Nf Pegylax which is product labeled by Martin Ekwealor Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 58607-700-57 527 g in 1 bottle . 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 Polyethylene Glycol 3350 Nf Pegylax?

1. Note: This product cap is for dosing. A capful contains about 17 grams of powder.2. Daily dose is 17 grams per day or as directed by physician.3. pour 17 grams (about 1 heaping tablespoon) of powder into a cup.4. Stir the powder in 4 to 8 oz. of water, juice, soda, coffee or tea until completely dissolved.5. Drink the solution.6. Treatment for 2 to 4 days may required to produce a bowel movement.Keep this and all medications out of the reach of children.Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30°(59° - 86° F). (See USP Controlled Room Temperature)Lot # and Exp. Date:Open here for more product information

Which are Polyethylene Glycol 3350 Nf Pegylax UNII Codes?

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

  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (Active Moiety)

What is the NDC to RxNorm Crosswalk for Polyethylene Glycol 3350 Nf Pegylax?

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: 1488067 - PEGyLAX 17 GM Powder for Oral Solution
  • RxCUI: 1488067 - polyethylene glycol 3350 17000 MG Powder for Oral Solution [Pegylax]
  • RxCUI: 1488067 - Pegylax 17 GM Powder for Oral Solution
  • RxCUI: 876193 - polyethylene glycol 3350 17 GM Powder for Oral Solution
  • RxCUI: 876193 - polyethylene glycol 3350 17000 MG Powder for Oral Solution

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Product Footnotes

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

[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, 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".