NDC 67544-840-80 Diclofenac Sodium

NDC Package Code 67544-840-80

The NDC Code 67544-840-80 is assigned to a package of 180 tablet, delayed release in 1 bottle, plastic of Diclofenac Sodium, labeled by Aphena Pharma Solutions - Tennessee, Inc.. The product's dosage form is and is administered via form.

Field Name Field Value
NDC Code 67544-840-80
Package Description 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Proprietary Name Diclofenac Sodium 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.
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.
Drug Uses Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). 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.
11-Digit NDC Billing Format 67544084080 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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.
Labeler Name Aphena Pharma Solutions - Tennessee, Inc.
Dosage Form -
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Start Marketing Date 03-26-1996 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2017 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.
Exclude Flag I 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".
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Code Structure

  • 67544 - Aphena Pharma Solutions - Tennessee, Inc.
    • 67544-840 - Diclofenac Sodium
      • 67544-840-80 - 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Pill Identification

Diclofenac Sodium 50 MG Delayed Release Oral Tablet

Diclofenac Sodium 50 MG Delayed Release Oral Tablet
Image Labeler: Actavis Elizabeth LLC

Physical Characteristics

What does diclofenac sodium look like?
Diclofenac Sodium may look like a white round shaped ; approximately 9 millimeters in size. The medicine is imprinted with black printed code(s) R and 550.

Shape: ROUND
Size: 9 mm
Color: WHITE
Imprint: R;550
Imprint Color: BLACK
Imprint Type: PRINTED

Active and Inactive Ingredients

Active Ingredients: diclofenac sodium 50 mg

Inactive Ingredients: silicon dioxide, hypromelloses, lactose monohydrate, magnesium stearate, cellulose, microcrystalline, polyethylene glycol, polysorbate 80, propylene glycol, silicon dioxide, sodium alginate, sodium starch glycolate type a potato, stearic acid, ferrosoferric oxide, talc, titanium dioxide

Other Product Packages

The following packages are also available for Diclofenac Sodium with product NDC 67544-840.

NDC Package CodePackage Description
67544-840-5360 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
67544-840-6090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.