Ortho-novum
NDC Package 50458-178-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ortho-novum is this combination hormone medication is used to prevent pregnancy. Marketed by Janssen Pharmaceuticals, Inc., this product is identified by NDC 50458-178 and is authorized under FDA application NDA018985.

Identification & Billing

NDC Package Code
50458-178-20
Package Description
48 DIALPACK in 1 CARTON / 1 KIT in 1 DIALPACK (50458-178-00)
Product Code
11-Digit Billing Format
50458017820
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
48 EA

Clinical Specifications

Proprietary Name
Ortho-novum 777
Dosage Form
-
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Janssen Pharmaceuticals, Inc.
FDA Application #
NDA018985
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-04-1984
End Marketing Date
01-22-2021
Listing Expiration
01-22-2021
Exclude Flag
D
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 (50458-178). Click a package code to view its specific billing and regulatory data.

12 DIALPACK in 1 CARTON / 1 KIT in 1 DIALPACK (50458-178-00)
6 DIALPACK in 1 CARTON / 1 KIT in 1 DIALPACK (50458-178-00)

* 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 50458-178-20 identifies a specific commercial package of 48 dialpack in 1 carton / 1 kit in 1 dialpack (50458-178-00) of Ortho-novum 777, labeled by Janssen Pharmaceuticals, Inc.. 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 Janssen Pharmaceuticals, Inc. on April 04, 1984. The current certification is valid through January 22, 2021.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Janssen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458017820. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 48 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:

10-Digit Format (5-3-2)
50458-178-20
11-Digit CMS (5-4-2)
50458-0178-20

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