Norethindrone Acetate Tablet
NDC Package 42291-650-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Norethindrone Acetate (norethindrone) tablets is a medication used to treat women with abnormal bleeding from the uterus. This formulation utilizes a tablet delivery system. Marketed by Avkare, this product is identified by NDC 42291-650 and is authorized under FDA application ANDA200275.

Identification & Billing

NDC Package Code
42291-650-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
42291-650
11-Digit Billing Format
42291065090
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
RxCUI: 1000405 - norethindrone acetate 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Norethindrone Acetate
Non-Proprietary Name
Norethindrone
Substance Name
Norethindrone Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORETHINDRONE ACETATE 5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat women with abnormal bleeding from the uterus. It is also used to treat women who have stopped having menstrual periods for several months (amenorrhea) but who are not pregnant or going through menopause. In addition, this medication is used to treat a condition (endometriosis) in which tissue that normally lines the inside of the uterus is found outside the uterus in the abdomen/pelvic area, causing painful/irregular periods. Norethindrone is a type of female hormone (progestin). It is like the hormone progesterone that your body makes naturally. This medication works by stopping the normal growth of the uterus lining during the menstrual cycle and signaling hormone changes in the uterus to restore normal menstrual periods. This medication must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA200275
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-18-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-650-90 identifies a specific commercial package of 90 tablet in 1 bottle of Norethindrone Acetate, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet is formulated for oral use and contains norethindrone acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avkare on June 18, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat women with abnormal bleeding from the uterus. It is also used to treat women who have stopped having menstrual periods for several months (amenorrhea) but who are not pregnant or going through menopause. In addition, this medication is used to treat a condition (endometriosis) in which tissue that normally lines the inside of the uterus is found outside the uterus in the abdomen/pelvic area, causing painful/irregular periods. Norethindrone is a type of female hormone (progestin). It is like the hormone progesterone that your body makes naturally. This medication works by stopping the normal growth of the uterus lining during the menstrual cycle and signaling hormone changes in the uterus to restore normal menstrual periods. This medication must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291065090. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42291-650-90
11-Digit CMS (5-4-2)
42291-0650-90

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.