Polyethylene Glycol 3350 Nf
NDC 42576-180
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Polyethylene Glycol 3350 Nf is a ANDA-approved product labeled by Nuvo Pharmaceutical Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 42576-180 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
42576-180
Proprietary Name:
Polyethylene Glycol 3350 Nf
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
42576
Product Label ID:
FDA Application Number: [6]
ANDA206105
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
07-03-2017
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325)
Code Structure Chart
Product Details
What is NDC 42576-180?
The NDC code 42576-180 is assigned by the FDA to the product Polyethylene Glycol 3350 Nf. This pharmaceutical product is labeled by Nuvo Pharmaceutical Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 42576-180-19, 42576-180-28, 42576-180-50. 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?
Do not take more than directed unless advised by your doctorthe bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)adults and children 17 years of age and older:○ fill to top of clear section in cap which is marked to indicate 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 day○ use no more than 7 dayschildren 16 years of age or under: ask a doctor
Which are the associated 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 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: 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 & 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 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".
