Estradiol Tablet
NDC Package 82804-319-30

11-digit billing NDC: 82804031930
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Estradiol tablets are indicated in the:1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. This formulation utilizes a tablet delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-319 and is authorized under FDA application ANDA217334.

Identification & Billing

NDC Package Code
82804-319-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
82804-319
11-Digit Billing Format
82804031930

Clinical Specifications

Proprietary Name
Estradiol
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
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)
ESTRADIOL 2 mg/1
Pharmacologic Class
Usage Information
Estradiol tablets are indicated in the:1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA217334
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-06-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82804-319-30 identifies a specific commercial package of 30 tablet in 1 bottle of Estradiol, a human prescription drug labeled by Proficient Rx Lp. This tablet is formulated for oral use and contains 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 Proficient Rx Lp on September 06, 2023. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804031930. 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)
82804-319-30
11-Digit CMS (5-4-2)
82804-0319-30

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