Fetzima Kit
NDC 0456-2200
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Fetzima (levomilnacipran hydrochloride) is a NDA-approved product labeled by Allergan, Inc.. Levomilnacipran is used to treat depression. It is supplied as a kit for oral administration. This product entry covers the primary NDC 0456-2200 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0456-2200
Proprietary Name:
Fetzima
Non-Proprietary Name: [1]
Levomilnacipran Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0456
Product Label ID:
FDA Application Number: [6]
NDA204168
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-24-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0456-2200?
The NDC code 0456-2200 is assigned by the FDA to the product Fetzima. It is commonly known by its generic name, levomilnacipran hydrochloride. This pharmaceutical product is labeled by Allergan, Inc. and is currently categorized as listed product. The medication is a kit administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0456-2200-07. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Levomilnacipran is used to treat depression. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. Levomilnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It may improve your mood, sleep, and appetite and may help restore your interest in daily living.
What is the NDC to RxNorm Crosswalk for this product?
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: 1433217 - levomilnacipran 120 MG 24HR Extended Release Oral Capsule
- RxCUI: 1433217 - 24 HR levomilnacipran 120 MG Extended Release Oral Capsule
- RxCUI: 1433217 - levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral Capsule
- RxCUI: 1433223 - Fetzima 120 MG 24HR Extended Release Oral Capsule
- RxCUI: 1433223 - 24 HR levomilnacipran 120 MG Extended Release Oral Capsule [Fetzima]
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Product & Regulatory Definitions
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
