Odefsey
NDC 50090-2340

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-2340?
  5. Odefsey 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 inactivated by the FDA.

Odefsey is a NDA-approved product labeled by A-s Medication Solutions. This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir alafenamide. It is supplied as a gray product. This product entry covers the primary NDC 50090-2340 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50090-2340
Proprietary Name:
Odefsey
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
f8689541-6526-47a5-9ff5-b8fc39ef4099
FDA Application Number: [6]
NDA208351
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-01-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GRAY (C48324)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
GSI;255
Score:
1

Code Structure Chart

Product Details

What is NDC 50090-2340?

The NDC code 50090-2340 is assigned by the FDA to the product Odefsey. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-2340-0. 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?

This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir alafenamide. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Emtricitabine and tenofovir alafenamide belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine/rilpivirine/tenofovir alafenamide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 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: 1741733 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet
  • RxCUI: 1741733 - emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet
  • RxCUI: 1741739 - ODEFSEY 200 MG / 25 MG/ 25 MG Oral Tablet
  • RxCUI: 1741739 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet [Odefsey]
  • RxCUI: 1741739 - Odefsey (emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG)) Oral Tablet

* Please review the full disclaimer at the bottom of this page.

Patient Education

Emtricitabine, Rilpivirine, and Tenofovir


The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV in adults and children who weigh at least 77 pounds (35 kilograms). Emtricitabine, rilpivirine, and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine, rilpivirine, and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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".