Bijuva Capsule
NDC Package 68308-751-00

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

Bijuva (estradiol and progesterone) capsules is this medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). This formulation utilizes a capsule delivery system. Marketed by Mayne Pharma, this product is identified by NDC 68308-751 and is authorized under FDA application NDA210132.

Identification & Billing

NDC Package Code
68308-751-00
Package Description
1 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK
Product Code
68308-751
11-Digit Billing Format
68308075100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bijuva
Non-Proprietary Name
Estradiol And Progesterone
Substance Name
Estradiol; Progesterone
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.

Regulatory & Marketing

Labeler Name
Mayne Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA210132
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68308-751). Click a package code to view its specific billing and regulatory data.

68308-751-30
1 BLISTER PACK in 1 CARTON / 30 CAPSULE in 1 BLISTER PACK

* 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 68308-751-00 identifies a specific commercial package of 1 blister pack in 1 carton / 5 capsule in 1 blister pack of Bijuva, a human prescription drug labeled by Mayne Pharma. This capsule is formulated for oral use and contains estradiol; progesterone 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 Mayne Pharma on December 01, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308075100. 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)
68308-751-00
11-Digit CMS (5-4-2)
68308-0751-00

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