Aygestin
NDC Package 51285-424-10
Package Information
Aygestin is a medication used to treat women with abnormal bleeding from the uterus. Marketed by Teva Women's Health Llc, this product is identified by NDC 51285-424 and is authorized under FDA application ANDA075951.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51285 - Teva Women's Health Llc
- 51285-424 - Aygestin
- 51285-424-10 - 50 TABLET in 1 BOTTLE
- 51285-424 - Aygestin
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 51285-424-10 identifies a specific commercial package of 50 tablet in 1 bottle of Aygestin, labeled by Teva Women's Health Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Teva Women's Health Llc on June 12, 2003. The current certification is valid through August 31, 2024.
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 Teva Women's Health Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51285042410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.