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  4. NDC Product Code: 10144-427 Ampyra

NDC 10144-427 Ampyra

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10144-427?
  5. Ampyra 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 expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 10144-427 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:
10144-427
Proprietary Name:
Ampyra
Product Type: [3]
Labeler Name: [5]
Merz Pharmaceuticals, Llc
Labeler Code:
10144
Product Label ID:
550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783
FDA Application Number: [6]
NDA022250
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
03-01-2010
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
A;10
Score:
1

Code Structure Chart

Product Details

What is NDC 10144-427?

The NDC code 10144-427 is assigned by the FDA to the product Ampyra which is product labeled by Merz Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10144-427-60 60 tablet, film coated, 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 Ampyra?

Dalfampridine is used to improve walking in people with multiple sclerosis (MS). It is a potassium channel blocker. It is thought to work by improving nerve conduction.

Which are Ampyra UNII Codes?

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

Which are Ampyra 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 Ampyra?

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: 897021 - dalfampridine 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 897021 - 12 HR dalfampridine 10 MG Extended Release Oral Tablet
  • RxCUI: 897021 - dalfampridine 10 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 897025 - Ampyra 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 897025 - 12 HR dalfampridine 10 MG Extended Release Oral Tablet [Ampyra]

* Please review the disclaimer below.

Patient Education

Dalfampridine


Dalfampridine is used to improve walking in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and may cause weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Dalfampridine may be used alone or with other medications that control the symptoms of MS. Dalfampridine is in a class of medications called potassium channel blockers. It works by strengthening the signals sent by the brain through nerves that have been damaged by MS.
[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.

[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".