Angeliq Tablet, Film Coated
NDC Package 50419-482-72

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

Package Information

Angeliq (drospirenone and estradiol) tablets is a medication used to reduce menopause symptoms. This formulation utilizes a tablet, film coated delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-482 and is authorized under FDA application NDA021355.

Identification & Billing

NDC Package Code
50419-482-72
Package Description
1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71)
Product Code
50419-482
11-Digit Billing Format
50419048272
RxNorm Crosswalk
  • RxCUI: 1483549 - drospirenone 0.25 MG / estradiol 0.5 MG Oral Tablet
  • RxCUI: 1483550 - {28 (drospirenone 0.25 MG / estradiol 0.5 MG Oral Tablet) } Pack
  • RxCUI: 1483550 - Drospiren-Estra 0.25-0.5 (28) Oral Tablet 28 Day Pack
  • RxCUI: 1483551 - {28 (drospirenone 0.25 MG / estradiol 0.5 MG Oral Tablet) } Pack [Angeliq 0.25/0.5 28 Day]
  • RxCUI: 1483551 - Angeliq 0.25/0.5 28 Day Pack

Clinical Specifications

Proprietary Name
Angeliq
Non-Proprietary Name
Drospirenone And Estradiol
Substance Name
Drospirenone; Estradiol
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of female hormone (estrogen). This medication is a combination of 2 types of female hormones: an estrogen (estradiol) and a progestin (drospirenone). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication. If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021355
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-29-2012
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50419-482). Click a package code to view its specific billing and regulatory data.

50419-482-03
3 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)

* 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 50419-482-72 identifies a specific commercial package of 1 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack (50419-482-71) of Angeliq, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains drospirenone; estradiol 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 Bayer Healthcare Pharmaceuticals Inc. on February 29, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to reduce menopause symptoms. It helps reduce episodes of flushing and sweating of the upper body and face, commonly called hot flashes. It also helps treat dryness, itching, and burning around the vagina. These symptoms occur when a woman's body no longer makes the usual amount of female hormone (estrogen). This medication is a combination of 2 types of female hormones: an estrogen (estradiol) and a progestin (drospirenone). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication. If you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419048272. 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)
50419-482-72
11-Digit CMS (5-4-2)
50419-0482-72

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