Etodolac Capsule
NDC 51655-166
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Etodolac is a ANDA-approved product labeled by Northwind Health Company, Llc. Etodolac is used to relieve pain from various conditions. It is supplied as a white capsule for oral administration. This product entry covers the primary NDC 51655-166 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
51655-166
Proprietary Name:
Etodolac
Non-Proprietary Name: [1]
Etodolac
Substance Name: [2]
Etodolac
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Capsule
- A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
51655
Product Label ID:
FDA Application Number: [6]
ANDA075419
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-13-2014
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
GRAY (C48324)
GRAY (C48324)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
Imprint(s):
APO;040
Score:
1
Code Structure Chart
Product Details
What is NDC 51655-166?
The NDC code 51655-166 is assigned by the FDA to the product Etodolac. This pharmaceutical product is labeled by Northwind Health Company, Llc and is currently categorized as listed product. The medication is a capsule administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 51655-166-52. 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?
Etodolac is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
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.
- ETODOLAC 300 mg/1 - A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (POSTOPERATIVE PAIN).
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ETODOLAC (UNII: 2M36281008)
- ETODOLAC (UNII: 2M36281008) (Active Moiety)
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 code indicates a single concept unique identifier (RXCUI) is associated with this product:
- RxCUI: 197685 - etodolac 300 MG Oral Capsule
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.
* Please review the full disclaimer at the bottom of this page.
Patient Education
Etodolac
Etodolac tablets, capsules, and extended-release (long-acting) tablets are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Etodolac tablets and capsules are also used to relieve pain from other causes. Etodolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
[Learn More]
Pain Relievers
Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.
Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.
If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.
There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.
[Learn More]
* 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 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".
