NDC 65162-833 Diclofenac Sodium
Diclofenac Gel Topical

Product Information

Diclofenac Sodium is a human prescription drug product labeled by Amneal Pharmaceuticals Llc. The generic name of Diclofenac Sodium is diclofenac. The product's dosage form is gel and is administered via topical form.

Product Code65162-833
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Diclofenac Sodium
Non-Proprietary Name 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.
Diclofenac
Product Type 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.
Human Prescription Drug
Dosage FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Amneal Pharmaceuticals Llc
Labeler Code65162
FDA Application Number 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.
ANDA208077
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-21-2016
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Diclofenac Sodium?


Product Packages

NDC 65162-833-66

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE

Price per Unit: $0.08376 per GM

Product Details

What are Diclofenac Sodium Active Ingredients?

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.
  • DICLOFENAC SODIUM 10 mg/g - A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

NDC to RxNorm Crosswalk

What is RxNorm? 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:

Pharmacologic Class(es)

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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Patient Education

Diclofenac Topical (actinic keratosis)

Diclofenac Topical (actinic keratosis) is pronounced as (dye kloe' fen ak)

Why is diclofenac topical (actinic keratosis) medication prescribed?
Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medica...
[Read More]

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Diclofenac Sodium Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Isopropyl Alcohol, 70% v/v


Purpose



Antiseptic


Uses



  • Antiseptic cleanser
  • Kills harmful bacteria and germs
  • First aid help prevent infection

Warnings



  • For External Use Only
  • Avoid contact with the eyes. If contact occurs, flush eyes with water

Do Not Use



  • With electrocautery procedures
  • In the eyes

Stop Use And Ask A Doctor If



  • Irritation and redness develops
  • If condition persists for more than 72 hours, consult a physician

Discontinue Use And Consult A Healthcare Practitioner If



  • Irritation develops

Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center right away

Directions



  • Use as part of your daily cleansing routine
  • May be covered with a sterile bandage

Other Information



  • Store at room temperature 15°-30°C (59°-86°F)
  • Avoid excessive heat

Inactive Ingredients



Water


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