Propofol Injectable Emulsion Injection, Emulsion
NDC 43598-265

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 43598-265?
  4. Propofol Injectable Emulsion Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Propofol Injectable Emulsion is a ANDA-approved product labeled by Dr. Reddy's Laboratories, Inc.. This medication is typically used as a general anesthesia [pe]. It is supplied as a injection, emulsion for intravenous administration. This product entry covers the primary NDC 43598-265 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43598-265
Proprietary Name:
Propofol Injectable Emulsion
Non-Proprietary Name: [1]
Propofol Injectable Emulsion
Substance Name: [2]
Propofol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Dr. Reddy's Laboratories, Inc.
Labeler Code:
43598
Product Label ID:
800646b8-83a8-01d9-3dc8-bb2ddcb8570c
HCPCS Code:
J2704 - INJECTION, PROPOFOL, 10 MG
FDA Application Number: [6]
ANDA205067
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-15-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 43598-265?

The NDC code 43598-265 is assigned by the FDA to the product Propofol Injectable Emulsion. This pharmaceutical product is labeled by Dr. Reddy's Laboratories, Inc. and is currently categorized as listed product. The medication is a injection, emulsion administered via intravenous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 43598-265-25, 43598-265-58. 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?

Propofol injectable emulsion, USP is an IV general anesthetic and sedation drug that  can be used as described in the table below.. Table 3. Indications for Propofol Injectable Emulsion, USP IndicationApproved Patient PopulationInitiation and maintenance of MonitoredAdults onlyAnesthesia Care (MAC) sedationCombined sedation and regional anesthesia Adults only (see PRECAUTIONS)Induction of General Anesthesia Maintenance of General AnesthesiaPatients greater than or equal to 3 years of age Patients greater than or equal to 2 months of ageIntensive Care Unit (ICU) sedation of intubated, mechanically ventilated patientsAdults onlySafety, effectiveness and dosing guidelines for propofol injectable emulsion, USP have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use). Propofol injectable emulsion, USP is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.In the Intensive Care Unit (ICU), propofol injectable emulsion, USP can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.Propofol injectable emulsion, USP is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PRECAUTIONS, Pediatric Use). Propofol injectable emulsion, USP is not recommended for obstetrics, including Cesarean section deliveries. Propofol injectable emulsion, USP crosses the placenta, and as with other general anesthetic agents, the administration of propofol injectable emulsion, USP may be associated with neonatal depression (see PRECAUTIONS).Propofol injectable emulsion, USP is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol, USP are not known (see PRECAUTIONS).

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.
  • PROPOFOL 10 mg/mL - An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive 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:

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.

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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".