Bijuva
NDC Package 50261-251-05

11-digit billing NDC: 50261025105
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Bijuva is contraindicated in women with any of the following conditions:Abnormal genital bleeding of unknown etiology [see Warnings and Precautions (5.2)].Breast cancer or a history of breast cancer [see Warnings and Precautions (5.2)].Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)].Active deep vein thrombosis (DVT), pulmonary embolisum (PE), or history of these conditions [see Warnings and Precautions (5.1)].Active arterial thromboembolic disease (for example, stroke, myocardial infarction (MI)), or a history of these conditions [see Warnings and Precautions (5.1)].Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA.Hepatic impairment or disease [see Warnings and Precautions (5.8)]Known thrombophilic disorders, such as protein C, protein S, or antithrombin deficiency. Marketed by Mayne Pharma Llc, this product is identified by NDC 50261-251 and is authorized under FDA application NDA210132.

Identification & Billing

NDC Package Code
50261-251-05
Package Description
1 BLISTER PACK in 1 CARTON / 5 CAPSULE in 1 BLISTER PACK
Product Code
50261-251
11-Digit Billing Format
50261025105
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bijuva
Dosage Form
-
Usage Information
BIJUVA is contraindicated in women with any of the following conditions:Abnormal genital bleeding of unknown etiology [see Warnings and Precautions (5.2)].Breast cancer or a history of breast cancer [see Warnings and Precautions (5.2)].Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)].Active deep vein thrombosis (DVT), pulmonary embolisum (PE), or history of these conditions [see Warnings and Precautions (5.1)].Active arterial thromboembolic disease (for example, stroke, myocardial infarction (MI)), or a history of these conditions [see Warnings and Precautions (5.1)].Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA.Hepatic impairment or disease [see Warnings and Precautions (5.8)]Known thrombophilic disorders, such as protein C, protein S, or antithrombin deficiency

Regulatory & Marketing

Labeler Name
Mayne Pharma Llc
FDA Application #
NDA210132
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-31-2023
Listing Expiration
12-31-2027
Exclude Flag
I
Sample Package
Yes

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 (50261-251). Click a package code to view its specific billing and regulatory data.

50261-251-30
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 50261-251-05 identifies a specific commercial package of 1 blister pack in 1 carton / 5 capsule in 1 blister pack of Bijuva, labeled by Mayne Pharma Llc. 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 Mayne Pharma Llc on March 31, 2023. The current certification is valid through December 31, 2027.

How is this Mayne Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50261025105. 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)
50261-251-05
11-Digit CMS (5-4-2)
50261-0251-05

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