Water Injection
NDC 83155-103
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Water is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Assure Infusions, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection for intravenous administration. This product entry covers the primary NDC 83155-103 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
83155-103
Proprietary Name:
Water
Non-Proprietary Name: [1]
Water
Substance Name: [2]
Water
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection
- A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
83155
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing Timeline
Start Marketing Date: [9]
04-16-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 83155-103?
The NDC code 83155-103 is assigned by the FDA to the product Water. This pharmaceutical product is labeled by Assure Infusions, Inc. and is currently categorized as listed product. The medication is a injection administered via intravenous route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 83155-103-10, 83155-103-25, 83155-103-50. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- WATER 250 mL/250mL - A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
- WATER (UNII: 059QF0KO0R) (Active Moiety)
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".
