Isoniazid Tablet
NDC 64950-216

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64950-216?
  5. Isoniazid Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Isoniazid is a ANDA-approved product labeled by Genus Lifesciences. Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 64950-216 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64950-216
Proprietary Name:
Isoniazid
Non-Proprietary Name: [1]
Isoniazid
Substance Name: [2]
Isoniazid
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Genus Lifesciences
Labeler Code:
64950
Product Label ID:
f0b46d1d-2300-457d-a7bd-a88a3f8d2235
FDA Application Number: [6]
ANDA080936
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-01-2024
End Marketing Date: [10]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
G;L;01
Score:
2

Code Structure Chart

Product Details

What is NDC 64950-216?

The NDC code 64950-216 is assigned by the FDA to the product Isoniazid. This pharmaceutical product is labeled by Genus Lifesciences and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 64950-216-10. 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?

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ISONIAZID 100 mg/1 - Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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

Patient Education

Isoniazid


Isoniazid is used with other drugs to treat tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body). Isoniazid is also used with other drugs to treat people with latent (resting or nongrowing) TB including those in close contact with people who have active TB, a positive tuberculin skin test, human immunodeficiency virus (HIV), and those with pulmonary fibrosis (scarring of the lungs with an unknown cause). Isoniazid is in a class of medications called antituberculosis agents. It works by killing the bacteria that cause tuberculosis.
[Learn More]


Antibiotics


What are antibiotics?

Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.

Antibiotics can be taken in different ways:

  • Orally (by mouth). This could be pills, capsules, or liquids.
  • Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops.
  • Through an injection or intravenously (IV). This is usually for more serious infections.

What do antibiotics treat?

Antibiotics only treat certain bacterial infections, such as strep throat, urinary tract infections, and E. coli.

You may not need to take antibiotics for some bacterial infections. For example, you might not need them for many sinus infections or some ear infections. Taking antibiotics when they're not needed won't help you, and they can have side effects. Your health care provider can decide the best treatment for you when you're sick. Don't ask your provider to prescribe an antibiotic for you.

Do antibiotics treat viral infections?

Antibiotics do not work on viral infections. For example, you shouldn't take antibiotics for:

What are the side effects of antibiotics?

The side effects of antibiotics range from minor to very severe. Some of the common side effects include:

More serious side effects can include:

Call your health care provider if you develop any side effects while taking your antibiotic.

Why is it important to take antibiotics only when they're needed?

You should only take antibiotics when they are needed because they can cause side effects and can contribute to antibiotic resistance. Antibiotic resistance happens when the bacteria change and become able to resist the effects of an antibiotic. This means that the bacteria continue to grow.

How do I use antibiotics correctly?

When you take antibiotics, it is important that you take them responsibly:

  • Always follow the directions carefully. Finish your medicine even if you feel better. If you stop taking them too soon, some bacteria may survive and re-infect you.
  • Don't save your antibiotics for later.
  • Don't share your antibiotic with others.
  • Don't take antibiotics prescribed for someone else. This may delay the best treatment for you, make you even sicker, or cause side effects.

Centers for Disease Control and Prevention


[Learn More]


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

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 is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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 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.
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".