NDC 0722-7116 Polyethylene Glycol 3350, Nf Powder For Solution, Laxative

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) 0722-7116 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:
0722-7116
Proprietary Name:
Polyethylene Glycol 3350, Nf Powder For Solution, Laxative
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
0722
FDA Application Number: [6]
ANDA090812
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-07-2009
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 0722-7116?

The NDC code 0722-7116 is assigned by the FDA to the product Polyethylene Glycol 3350, Nf Powder For Solution, Laxative which is product labeled by Nexgen Pharma, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 0722-7116-01 7 d in 1 bottle , 0722-7116-02 14 d in 1 bottle , 0722-7116-03 30 d 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 Powder For Solution, Laxative?

Do not take more than directed unless advised by your doctorThe bottle top is a measuring cup designed to contain 17 grams of powder when filled to the top rim.adults and children 17 years of age and olderfill to the top of the bottle cap which will provide the correct dose (17 g)stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink.use once a dayuse no more than 7 dayschildren 16 years of age or younger, ask a doctor

Which are Polyethylene Glycol 3350, Nf Powder For Solution, Laxative 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 Powder For Solution, 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: 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.

[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, 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".