Lactated Ringers Injection, Solution
NDC 85766-311
4 active ingredients · Injection, Solution (intravenous)
Product Information
Lactated Ringers (sodium chloride, potassium chloride, sodium lactate and calcium chloride) is a NDA-approved product labeled by Sportpharm Llc. This medication is typically used as a blood coagulation factor [epc]. It is supplied as a injection, solution for intravenous administration. This product entry covers the primary NDC 85766-311 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
85766-311
Proprietary Name:
Lactated Ringers
Non-Proprietary Name: [1]
Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride
Substance Name: [2]
Sodium Chloride; Sodium Lactate; Potassium Chloride; Calcium Chloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Solution
- A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
85766
Product Label ID:
FDA Application Number: [6]
NDA016682
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-22-1971
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 85766-311?
The NDC code 85766-311 is assigned by the FDA to the product Lactated Ringers. It is commonly known by its generic name, sodium chloride, potassium chloride, sodium lactate and calcium chloride. This pharmaceutical product is labeled by Sportpharm Llc and is currently categorized as listed product. The medication is a injection, solution administered via intravenous route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 85766-311-00, 85766-311-25, 85766-311-50. 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?
Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.
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.
- SODIUM CHLORIDE 600 mg/100mL - A ubiquitous sodium salt that is commonly used to season food.
- SODIUM LACTATE 310 mg/100mL - The sodium salt of racemic or inactive lactic acid. It is a hygroscopic agent used intravenously as a systemic and urinary alkalizer.
- POTASSIUM CHLORIDE 30 mg/100mL - A white crystal or crystalline powder used in BUFFERS; FERTILIZERS; and EXPLOSIVES. It can be used to replenish ELECTROLYTES and restore WATER-ELECTROLYTE BALANCE in treating HYPOKALEMIA.
- CALCIUM CHLORIDE 20 mg/100mL - A salt used to replenish calcium levels, as an acid-producing diuretic, and as an antidote for magnesium poisoning.
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Calcium - [CS]
- Cations, Divalent - [CS]
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Phosphate Binder - [EPC] (Established Pharmacologic Class)
- Phosphate Chelating Activity - [MoA] (Mechanism of Action)
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
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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 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".
