Vanilla Silq Hd
NDC 69307-4496
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.
Vanilla Silq Hd is a UNAPPROVED DRUG OTHER-approved product labeled by Genus Medical Technologies, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 69307-4496 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
69307-4496
Proprietary Name:
Vanilla Silq Hd
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
69307
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
12-08-2015
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 69307-4496?
The NDC code 69307-4496 is assigned by the FDA to the product Vanilla Silq Hd. This pharmaceutical product is labeled by Genus Medical Technologies, Llc 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: 69307-4496-2. 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?
This product should not be used in patients with known or suspected gastric or intestinal perforation, patients with conditions that may increase the risk of perforation; hypersensitivity to barium sulfate products; suspected tracheoesophageal fistula; obstructing lesions of the small intestine; pyloric stenosis; inflammation or neoplastic lesions of the rectum; or in patients who have had a recent rectal biopsy.Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as nectrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BARIUM SULFATE (UNII: 25BB7EKE2E)
- BARIUM SULFATE (UNII: 25BB7EKE2E) (Active Moiety)
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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 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".
