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  4. NDC Product Code: 71921-194 Entecavir

NDC 71921-194 Entecavir

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71921-194?
  5. Entecavir Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 71921-194 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:
71921-194
Proprietary Name:
Entecavir
Product Type: [3]
Labeler Name: [5]
Florida Pharmaceutical Products, Llc
Labeler Code:
71921
Product Label ID:
b94edc56-4d7e-df7a-e053-2a95a90afcf4
FDA Application Number: [6]
ANDA212106
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
02-26-2021
End Marketing Date: [10]
05-31-2024
Listing Expiration Date: [11]
05-31-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
57;P
Score:
1

Code Structure Chart

Product Details

What is NDC 71921-194?

The NDC code 71921-194 is assigned by the FDA to the product Entecavir which is product labeled by Florida Pharmaceutical Products, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 71921-194-33 30 tablet in 1 bottle . 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 Entecavir?

See also Warning section. Entecavir is used to treat long-term hepatitis B infection. Hepatitis B is an infection of the liver caused by the hepatitis B virus. Long-term infection can cause liver damage, rarely liver cancer, and liver failure. Entecavir helps to decrease the amount of hepatitis B virus in your body. It is unknown if this medication lowers your chance of getting liver cancer or liver damage. Entecavir is an antiviral that belongs to a class of drugs known as hepatitis B virus nucleoside reverse transcriptase inhibitors. Entecavir is not a cure for hepatitis B. It does not prevent the spread of the virus to others through sexual contact or blood/body fluid contamination (such as sharing used needles).

Which are Entecavir UNII Codes?

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

Which are Entecavir 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:

* Please review the disclaimer below.

Patient Education

Entecavir


Entecavir is used to treat chronic (long-term) hepatitis B infection (swelling of the liver caused by a virus) in adults and children 2 years of age and older who have liver damage. Entecavir is in a class of medications called nucleoside analogs. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Entecavir does not cure HBV and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Entecavir does not prevent the spread of HBV to other people.
[Learn More]


* 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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".