Estring
NDC Package 63539-021-01
Package Information
Estring is a medication a female hormone (estrogen). Marketed by U.s. Pharmaceuticals, this product is identified by NDC 63539-021 and is authorized under FDA application NDA020472.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63539 - U.s. Pharmaceuticals
- 63539-021 - Estring
- 63539-021-01 - 1 RING in 1 POUCH
- 63539-021 - Estring
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 63539-021-01 identifies a specific commercial package of 1 ring in 1 pouch of Estring, labeled by U.s. Pharmaceuticals. 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 U.s. Pharmaceuticals on April 26, 1996. The current certification is valid through August 31, 2021.
What are the primary indications for this medication?
This medication is a female hormone (estrogen). It is used by women to help reduce vaginal and urinary symptoms of menopause (such as vaginal dryness/burning/itching, painful urination, frequent urges to urinate). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.
How is this U.s. Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63539002101. 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.