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  4. NDC Product Code: 53808-0887 Stribild

NDC 53808-0887 Stribild

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53808-0887?
  5. Stribild 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) 53808-0887 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:
53808-0887
Proprietary Name:
Stribild
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
State Of Florida Doh Central Pharmacy
Labeler Code:
53808
Product Label ID:
144067b2-0532-476a-996e-e4a0a9d09b05
FDA Application Number: [6]
NDA203100
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
01-01-2014
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329)
Shape:
OVAL (C48345)
Size(s):
20 MM
Imprint(s):
GSI;1
Score:
1

Code Structure Chart

Product Details

What is NDC 53808-0887?

The NDC code 53808-0887 is assigned by the FDA to the product Stribild which is product labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53808-0887-1 30 tablet, film coated in 1 blister 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 Stribild?

This product 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. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor; they are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/tenofovir 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 Stribild UNII Codes?

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

Which are Stribild 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 Stribild?

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: 1306292 - elvitegravir 150 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1306292 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1306292 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet
  • RxCUI: 1306298 - Stribild 150 MG / 150 MG / 200 MG / 300 MG Oral Tablet
  • RxCUI: 1306298 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Stribild]

* 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".