Meijer
NDC 41250-112

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.

Meijer is a OTC MONOGRAPH NOT FINAL-approved product labeled by Meijer Distribution Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 41250-112 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
41250-112
Proprietary Name:
Meijer
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
41250
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]
05-10-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 41250-112?

The NDC code 41250-112 is assigned by the FDA to the product Meijer. This pharmaceutical product is labeled by Meijer Distribution Inc 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: 41250-112-11. 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?

Single daily doseadults & children 12 years and over1 bottle once dailychildren 2 to under12 years1/2 bottle once dailyDiscard unused portionchildren under2 yearsdo not useHow to use this enema:REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE. Administering enema:•With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.•Do not force the enema tip into rectum as this can cause injury.•Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. •Remove enema tip from rectum.•Retain enema in accordance with doctor's instructions. Positioning:Left-side position: Lie on left side with knee bent and arms at rest.Knee-chest position:Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Which are the associated UNII Codes?

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

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:

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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".