Minolira Extended Release
NDC 71403-102

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71403-102?
  5. Minolira Extended Release 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.

Minolira Extended Release is a NDA-approved product labeled by Epi Health, Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 71403-102 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
71403-102
Proprietary Name:
Minolira Extended Release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Epi Health, Inc
Labeler Code:
71403
Product Label ID:
523856a4-530b-4a23-a80a-d72ab08e2c08
FDA Application Number: [6]
NDA209269
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-15-2019
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
RECTANGLE (C48347)
Size(s):
20 MM
Imprint(s):
M3
Score:
2

Code Structure Chart

Product Details

What is NDC 71403-102?

The NDC code 71403-102 is assigned by the FDA to the product Minolira Extended Release. This pharmaceutical product is labeled by Epi Health, Inc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 71403-102-05, 71403-102-30. 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?

MINOLIRA is indicated to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

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: 1013659 - minocycline HCl 105 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1013659 - 24 HR minocycline 105 MG Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG 24 HR Extended Release Oral Tablet

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

Patient Education

Minocycline


Minocycline is used to treat infections caused by bacteria including pneumonia and other respiratory tract infections; certain infections of the skin, eye, lymphatic, intestinal, genital, and urinary systems; and certain other infections that are spread by ticks, lice, mites, and infected animals. It is also used along with other medications to treat acne. Minocycline is also used to treat plague and tuleramia (serious infections that may be spread on purpose as part of a bioterror attack). It can also be used in patients who cannot be treated with penicillin to treat certain types of food poisoning, and anthrax (a serious infection that may be spread on purpose as part of a bioterror attack). It can also be used to eliminate bacteria from your nose and throat that may cause meningitis (swelling of tissues around the brain) in others, even though you may not have an infection. Minocycline extended-release tablet (Solodyn) is only used to treat acne. Minocycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne. Antibiotics such as minocycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[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 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".