NDC 70257-563-02 Lioresal (baclofen)

Baclofen

NDC Package Code 70257-563-02

Field Name	Field Value
NDC Code	70257-563-02
Package Description	2 AMPULE in 1 BOX > 20 mL in 1 AMPULE (70257-563-20)
Proprietary Name	Lioresal (baclofen) What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Baclofen 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.
11-Digit NDC Billing Format	70257056302 NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type	Human Prescription Drug 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.
Labeler Name	Saol Therapeutics Inc.
Dosage Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)	Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)	BACLOFEN 40 mg/20mL
Pharmacological Class(es)	GABA A Agonists - [MoA] (Mechanism of Action) GABA B Agonists - [MoA] (Mechanism of Action) gamma-Aminobutyric Acid-ergic Agonist - [EPC] (Established Pharmacologic Class)
Sample Package	No Sample Package? This field Indicates whether this package is a sample packaging or not.
Marketing Category	NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number	NDA020075 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.
Start Marketing Date	07-05-2017 What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date	12-31-2020 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.

The NDC Code 70257-563-02 is assigned to Lioresal (baclofen), a human prescription drug labeled by Saol Therapeutics Inc.. The product's dosage form is injection and is administered via intrathecal form.

Code Structure

70257 - Saol Therapeutics Inc.
- 70257-563 - Lioresal (baclofen)
  - 70257-563-02 - 2 AMPULE in 1 BOX

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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 70257-563-02 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
70257056302	J0475	Baclofen 10 mg injection	10 MG	20	2	4	8

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Other Product Packages

The following packages are also available for Lioresal (baclofen) with product NDC 70257-563.

NDC Package Code	Package Description
70257-563-01	1 AMPULE in 1 BOX > 20 mL in 1 AMPULE (70257-563-20)

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