Angeliq
NDC Package 54868-6184-0
Package Information
Angeliq is a medication used to reduce menopause symptoms. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6184 and is authorized under FDA application NDA021355.
Identification & Billing
- RxCUI: 1483552 - drospirenone 0.5 MG / estradiol 1 MG Oral Tablet
- RxCUI: 1483553 - {28 (drospirenone 0.5 MG / estradiol 1 MG Oral Tablet) } Pack
- RxCUI: 1483553 - Drospiren-Eth estra 0.5-1 MG (28) Oral Tablet 28 Day Pack
- RxCUI: 1483553 - drospirenone 0.5 MG / Ethinyl Estradiol 1 MG 28 Oral Tablet Pack
- RxCUI: 1483554 - {28 (drospirenone 0.5 MG / estradiol 1 MG Oral Tablet) } Pack [Angeliq 0.5/1 28 Day]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-6184 - Angeliq
- 54868-6184-0 - 1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK
- 54868-6184 - Angeliq
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 54868-6184-0 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack of Angeliq, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Physicians Total Care, Inc. on September 29, 2010. The current certification is valid through December 31, 2017.
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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868618400. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 Package segment to maintain the 5-4-2 structure.