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  4. NDC Product Code: 69189-0701 Truvada

NDC 69189-0701 Truvada

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69189-0701?
  5. Truvada Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 69189-0701 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:
69189-0701
Proprietary Name:
Truvada
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Avera Mckennan Hospital
Labeler Code:
69189
Product Label ID:
032f734e-4969-46ae-a3b6-d8dcb4ccc482
FDA Application Number: [6]
NDA021752
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-01-2015
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
GILEAD;701
Score:
1

Code Structure Chart

Product Details

What is NDC 69189-0701?

The NDC code 69189-0701 is assigned by the FDA to the product Truvada which is product labeled by Avera Mckennan Hospital. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69189-0701-1 1 tablet, film coated in 1 dose pack . 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 Truvada?

This product is used with other HIV medications 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. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and 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 Truvada UNII Codes?

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

Which are Truvada 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 Truvada?

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: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet
  • RxCUI: 639888 - Truvada 200 MG / 300 MG Oral Tablet
  • RxCUI: 639888 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada]
  • RxCUI: 639888 - Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet

* 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".