Femcon Fe
NDC Package 54868-6161-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Femcon Fe is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6161 and is authorized under FDA application NDA021490.

Identification & Billing

NDC Package Code
54868-6161-0
Package Description
1 BLISTER PACK in 1 CELLO PACK / 1 KIT in 1 BLISTER PACK
Product Code
54868-6161
11-Digit Billing Format
54868616100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1095223 - ferrous fumarate 75 MG Chewable Tablet
  • RxCUI: 1095224 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1095224 - eth-estra-noreth 0.035-0.4 MG (21) Chewable Tablet / ferr fum 75 MG (7) Chewable Tablet 28 Day Pack
  • RxCUI: 1095224 - {21 (ethinyl estradiol 35 MCG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1244908 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack [Femcon Fe 28 Day]

Clinical Specifications

Proprietary Name
Femcon Fe
Dosage Form
-
Usage Information
FEMCON Fe is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology:Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.% of Women Experiencing an UnintendedPregnancy within the First Year of Use% of WomenContinuing Use at One Year Method (1)Typical Use (2)Perfect Use (3)(4)Chance 8585Spermicides 26 640Periodic abstinence2563      Calendar 9      Ovulation Method 3      Sympto-thermal 2      Post-Ovulation 1CapWith spermicidal cream or jelly      Parous Women402642      Nulliparous Women20 956Sponge      Parous Women402042      Nulliparous Women20 956Diaphragm20 656Withdrawal19 4Condom      Female (reality)21 556      Male14 361Pill 571      Progestin only0.5      Combined0.1IUD      Progesterone T2.01.581      Copper T 380A0.80.678      LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant® 20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75% Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021490
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-21-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-6161-0 identifies a specific commercial package of 1 blister pack in 1 cello pack / 1 kit in 1 blister pack of Femcon 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 September 21, 2010. The current certification is valid through December 31, 2017.

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: 54868616100. 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)
54868-6161-0
11-Digit CMS (5-4-2)
54868-6161-00

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