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  4. NDC Product Code: 55700-858 Cyclobenzaprine Hydrochloride

NDC 55700-858 Cyclobenzaprine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55700-858?
  5. Cyclobenzaprine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 55700-858 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
55700-858
Proprietary Name:
Cyclobenzaprine Hydrochloride
Product Type: [3]
Labeler Name: [5]
Quality Care Products, Llc
Labeler Code:
55700
Product Label ID:
f58894c3-301b-463a-853a-5ad39c082ab7
FDA Application Number: [6]
ANDA091281
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
04-17-2020
End Marketing Date: [10]
12-31-2022
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - DARK ORANGE OPAQUE CAP; RED OPAQUE BODY)
ORANGE (C48331 - ORANGE OPAQUE CAP; WHITE OPAQUE BODY)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
16 MM
Imprint(s):
T035
T036
Score:
1

Code Structure Chart

Product Details

What is NDC 55700-858?

The NDC code 55700-858 is assigned by the FDA to the product Cyclobenzaprine Hydrochloride which is product labeled by Quality Care Products, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 55700-858-60 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 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, 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.

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

* 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

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".