NDC 0093-1921 Cyclobenzaprine Hydrochloride

Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0093-1921
Proprietary Name:
Cyclobenzaprine Hydrochloride
Non-Proprietary Name: [1]
Cyclobenzaprine Hydrochloride
Substance Name: [2]
Cyclobenzaprine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Teva Pharmaceuticals Usa, Inc.
    Labeler Code:
    0093
    FDA Application Number: [6]
    NDA021777
    Marketing Category: [8]
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date: [9]
    03-04-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331)
    BLUE (C48333)
    RED (C48326)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    Imprint(s):
    15;MG;C;CEPHALON
    30;MG;C;CEPHALON
    Score:
    1

    Product Packages

    NDC Code 0093-1921-06

    Package Description: 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 0093-1921?

    The NDC code 0093-1921 is assigned by the FDA to the product Cyclobenzaprine Hydrochloride which is a human prescription drug product labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 0093-1921-06 60 capsule, extended release in 1 bottle . 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 Cyclobenzaprine Hydrochloride?

    Cyclobenzaprine hydrochloride extended-release capsules is 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, and limitation of motion.Limitations of Use:Cyclobenzaprine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.

    What are Cyclobenzaprine Hydrochloride Active Ingredients?

    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.

    Which are Cyclobenzaprine Hydrochloride UNII Codes?

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

    • CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P)
    • CYCLOBENZAPRINE (UNII: 69O5WQQ5TI) (Active Moiety)

    Which are Cyclobenzaprine Hydrochloride 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 Cyclobenzaprine Hydrochloride?

    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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 828353 - cyclobenzaprine HCl 30 MG 24HR Extended Release Oral Capsule
    • RxCUI: 828353 - 24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule
    • RxCUI: 828353 - cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral Capsule
    • RxCUI: 828358 - cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule
    • RxCUI: 828358 - 24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule

    Which are the Pharmacologic Classes for Cyclobenzaprine Hydrochloride?

    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 disclaimer below.

    Patient Education

    Cyclobenzaprine


    Cyclobenzaprine is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [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".