Polyethylene Glycol (3350)
Mylan Institutional Inc.
Human Otc Drug
NDC 51079-306Polyethylene Glycol (3350) is a human otc drug labeled by 'Mylan Institutional Inc.'. National Drug Code (NDC) number for Polyethylene Glycol (3350) is 51079-306. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Polyethylene Glycol (3350) drug includes Polyethylene Glycol 3500 - 17 g/17g . The currest status of Polyethylene Glycol (3350) drug is Active.
Drug Information:
| Drug NDC: | 51079-306 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Polyethylene Glycol (3350) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Polyethylene Glycol (3350) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mylan Institutional Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POLYETHYLENE GLYCOL 3500 - 17 g/17g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 12 Oct, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 May, 2026 |
| 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. |
| Application Number: | ANDA078915 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Mylan Institutional Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 876193
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | FVS1AZD90Y
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51079-306-30 | 30 POUCH in 1 CARTON (51079-306-30) / 17 g in 1 POUCH (51079-306-01) | 12 Oct, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose osmotic laxative
Product Elements:
Polyethylene glycol (3350) polyethylene glycol (3350) polyethylene glycol 3500 polyethylene glycol 3500
Indications and Usage:
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Warnings:
Warnings allergy alert: do not use if you are allergic to polyethylene glycol
Do Not Use:
Warnings allergy alert: do not use if you are allergic to polyethylene glycol
When Using:
When using this product you may have loose, watery, more frequent stools
Dosage and Administration:
Directions do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve the contents of one pouch (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do no drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor
Stop Use:
Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. these may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week
Package Label Principal Display Panel:
Principal display panel ndc 51079-306-30 polyethylene glycol 3350, usp powder for solution, osmotic laxative relieves occasional constipation/irregularity softens stool unflavored powder grit free sugar free dissolves in any beverage this carton contains 30 single-dose pouches. each pouch contains 17 grams of polyethylene glycol 3350, usp powder. for institutional use only. 30 single-dose pouches polyethylene glycol 3350 carton label
Further Questions:
Questions or comments? 1-877-4-info-rx (1-877-446-3679) manufactured for: mylan institutional inc. rockford, il 61103 u.s.a. mii306-30:r7