NDC Package 50268-190-15 Cyclobenzaprine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50268-190-15
Package Description:
50 BLISTER PACK in 1 BOX / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-190-11)
Product Code:
Proprietary Name:
Cyclobenzaprine Hydrochloride
Non-Proprietary Name:
Cyclobenzaprine Hydrochloride
Substance Name:
Cyclobenzaprine Hydrochloride
Usage Information:
Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
11-Digit NDC Billing Format:
50268019015
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
50 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 828320 - cyclobenzaprine HCl 5 MG Oral Tablet
  • RxCUI: 828320 - cyclobenzaprine hydrochloride 5 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Avpak
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA090478
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-10-2014
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Frequently Asked Questions

    What is NDC 50268-190-15?

    The NDC Packaged Code 50268-190-15 is assigned to a package of 50 blister pack in 1 box / 1 tablet, film coated in 1 blister pack (50268-190-11) of Cyclobenzaprine Hydrochloride, a human prescription drug labeled by Avpak. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 50268-190 included in the NDC Directory?

    Yes, Cyclobenzaprine Hydrochloride with product code 50268-190 is active and included in the NDC Directory. The product was first marketed by Avpak on June 10, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50268-190-15?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 50.

    What is the 11-digit format for NDC 50268-190-15?

    The 11-digit format is 50268019015. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250268-190-155-4-250268-0190-15