Nitrous Oxide
NDC 48883-004
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.
Nitrous Oxide is a UNAPPROVED MEDICAL GAS-approved product labeled by Encompass Medical & Specialty Gases, Ltd.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 48883-004 and 11 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
48883-004
Proprietary Name:
Nitrous Oxide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
48883
Product Label ID:
Marketing Category: [8]
UNAPPROVED MEDICAL GAS - A category specifying that a product is marketed as unapproved medical gas.
Marketing Timeline
Start Marketing Date: [9]
01-02-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 48883-004?
The NDC code 48883-004 is assigned by the FDA to the product Nitrous Oxide. This pharmaceutical product is labeled by Encompass Medical & Specialty Gases, Ltd. and is currently categorized as listed product. In terms of distribution, this product is available in 11 different package configurations. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- NITROUS OXIDE (UNII: K50XQU1029)
- NITROUS OXIDE (UNII: K50XQU1029) (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".
