Sharobel Kit
NDC 16714-441

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16714-441?
  5. Sharobel Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Sharobel (norethindrone) is a ANDA-approved product labeled by Northstar Rx Llc. This medication is used to prevent pregnancy. It is supplied as a green kit. This product entry covers the primary NDC 16714-441 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
16714-441
Proprietary Name:
Sharobel
Non-Proprietary Name: [1]
Norethindrone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Northstar Rx Llc
Labeler Code:
16714
Product Label ID:
a96f5194-ad2a-4783-a9a9-22a288caff25
FDA Application Number: [6]
ANDA200961
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-13-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
GREEN (C48329)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
V2
Score:
1

Code Structure Chart

Product Details

What is NDC 16714-441?

The NDC code 16714-441 is assigned by the FDA to the product Sharobel. It is commonly known by its generic name, norethindrone. This pharmaceutical product is labeled by Northstar Rx Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 16714-441-01, 16714-441-02, 16714-441-03, 16714-441-04. 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?

This medication is used to prevent pregnancy. It is often referred to as the "mini-pill" because it does not contain any estrogen. Norethindrone (a form of progestin) is a hormone that prevents pregnancy by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also stops the release of an egg (ovulation) in about half of a woman's menstrual cycles. While the "mini-pill" is more effective than certain other methods of birth control (such as condoms, cervical cap, diaphragm), it is less effective than combination hormone (estrogen and progestin) birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. To reduce the risk of pregnancy, it is very important to take this medication exactly as prescribed. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

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:

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Patient Education

Norethindrone


Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones. Norethindrone is also used to prevent pregnancy. Norethindrone is sold under different brand names and is taken in smaller amounts when it used to prevent pregnancy. This monograph does not include information on the use of norethindrone to prevent pregnancy. If you are taking norethindrone to prevent pregnancy, read the monograph entitled Progestin-Only (norethindrone) Oral Contraceptives.
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Progestin-Only (norethindrone) Oral Contraceptives


Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. Progestin-only (norethindrone) oral contraceptives are a very effective method of birth control, but they do not prevent the spread of AIDS and other sexually transmitted diseases.
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* 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 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 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".