NDC 61919-261-72 Cyclobenzaprine Hydrochloride

NDC Package Code 61919-261-72

The NDC Code 61919-261-72 is assigned to a package of 120 tablet, film coated in 1 bottle of Cyclobenzaprine Hydrochloride, labeled by Direct Rx. The product's dosage form is and is administered via form.

Field Name Field Value
NDC Code 61919-261-72
Package Description 120 TABLET, FILM COATED in 1 BOTTLE
Proprietary Name Cyclobenzaprine Hydrochloride 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.
11-Digit NDC Billing Format 61919026172 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 Direct Rx
Dosage Form -
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1
Pharmacological Class(es)
  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Start Marketing Date 01-01-2015 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 E 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. Values = ‘Y’ or ‘N’.
This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Code Structure

  • 61919 - Direct Rx
    • 61919-261 - Cyclobenzaprine Hydrochloride
      • 61919-261-72 - 120 TABLET, FILM COATED in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for Cyclobenzaprine Hydrochloride with product NDC 61919-261.

NDC Package CodePackage Description
61919-261-1515 TABLET, FILM COATED in 1 BOTTLE
61919-261-3030 TABLET, FILM COATED in 1 BOTTLE
61919-261-6060 TABLET, FILM COATED in 1 BOTTLE
61919-261-9090 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.