Estrostep Fe
NDC Package 54868-3948-0

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.

Estrostep Fe is this combination hormone medication is used to prevent pregnancy. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3948 and is authorized under FDA application NDA020130.

Identification & Billing

NDC Package Code
54868-3948-0
Package Description
1 BLISTER PACK in 1 CELLO PACK / 1 KIT in 1 BLISTER PACK
Product Code
11-Digit Billing Format
54868394800
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Estrostep Fe
Dosage Form
-
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (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. There is a small amount of iron (ferrous fumarate) in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. 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
Physicians Total Care, Inc.
FDA Application #
NDA020130
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2005
End Marketing Date
06-30-2010
Listing Expiration
06-30-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-3948-0 identifies a specific commercial package of 1 blister pack in 1 cello pack / 1 kit in 1 blister pack of Estrostep Fe, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on April 19, 2005. The current certification is valid through June 30, 2010.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (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. There is a small amount of iron (ferrous fumarate) in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. 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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868394800. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
54868-3948-0
11-Digit CMS (5-4-2)
54868-3948-00

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