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  4. NDC Product Code: 68387-345 Indomethacin Extended-release

NDC 68387-345 Indomethacin Extended-release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68387-345?
  5. Indomethacin Extended-release Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
68387-345
Proprietary Name:
Indomethacin Extended-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Keltman Pharmaceuticals Inc.
Labeler Code:
68387
Product Label ID:
3125cb9f-d00c-47e7-9927-fbe38cadb48b
Start Marketing Date: [9]
01-09-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329)
Shape:
CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
E720
Score:
1

Product Packages

NDC Code 68387-345-30

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 68387-345?

The NDC code 68387-345 is assigned by the FDA to the product Indomethacin Extended-release which is product labeled by Keltman Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68387-345-30 30 capsule in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Indomethacin Extended-release?

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Indomethacin extended-release capsules have been found effective in active stages of the following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease.2. Moderate to severe ankylosing spondylitis.3. Moderate to severe osteoarthritis.4. Acute painful shoulder (bursitis and/or tendinitis).Indomethacin extended-release capsules is not recommended for the treatment of acute gouty arthritis.Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS, Drug Interactions).

Which are Indomethacin Extended-release UNII Codes?

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

Which are Indomethacin Extended-release Inactive Ingredients 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 Indomethacin Extended-release?

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:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".