NDC 45865-386 Tizanidine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
45865-386
Proprietary Name:
Tizanidine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Medsource Pharmaceuticals
Labeler Code:
45865
Start Marketing Date: [9]
01-05-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
8 MM
Imprint(s):
RDY;179
Score:
2

Product Packages

NDC Code 45865-386-30

Package Description: 30 TABLET in 1 BOTTLE

NDC Code 45865-386-49

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 45865-386-51

Package Description: 120 TABLET in 1 BOTTLE

NDC Code 45865-386-60

Package Description: 60 TABLET in 1 BOTTLE

NDC Code 45865-386-90

Package Description: 90 TABLET in 1 BOTTLE

Product Details

What is NDC 45865-386?

The NDC code 45865-386 is assigned by the FDA to the product Tizanidine which is product labeled by Medsource Pharmaceuticals. The product's dosage form is . The product is distributed in 5 packages with assigned NDC codes 45865-386-30 30 tablet in 1 bottle , 45865-386-49 100 tablet in 1 bottle , 45865-386-51 120 tablet in 1 bottle , 45865-386-60 60 tablet in 1 bottle , 45865-386-90 90 tablet 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 Tizanidine?

Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).

Which are Tizanidine UNII Codes?

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

Which are Tizanidine 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 Tizanidine?

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:

* Please review the disclaimer below.

Patient Education

Tizanidine


Tizanidine is used to relieve the spasms and increased muscle tone caused by multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control), stroke, or brain or spinal injury. Tizanidine is in a class of medications called skeletal muscle relaxants. It works by slowing action in the brain and nervous system to allow the muscles to relax.
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Product Footnotes

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

[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".