Necon 1/35
NDC Package 54868-4045-0

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.

Necon 1/35 is necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 are 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 54868-4045 and is authorized under FDA application ANDA070687.

Identification & Billing

NDC Package Code
54868-4045-0
Package Description
1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
54868-4045
11-Digit Billing Format
54868404500
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Necon 1/35
Dosage Form
-
Usage Information
Necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 are 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 I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: 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.% of Women Experiencing anUnintended Pregnancywithin the First Year of Use% of WomenContinuing Useat One Year3 Method(1)Typical Use1 (2)Perfect Use2 (3)(4)Adapted from Hatcher et al., 1998 Ref. #1.1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.Chance4 8585Spermicides5 26  640Periodic abstinence 2563  Calendar  9  Ovulation Method  3  Sympto-Thermal6   2  Post-Ovulation  1Withdrawal 19  4Cap7   Parous Women402642  Nulliparous Women 20  956Sponge  Parous Women402042  Nulliparous Women 20  956Diaphragm7 20  656Condom8   Female (Reality)21  556  Male14  361Pill  571  Progestin Only      0.5  Combined      0.1IUD  Progesterone T      2.0      1.581  Copper T380A      0.8      0.678  LNg 20      0.1      0.181Depo–Provera      0.3      0.370Norplant and Norplant-2        0.05        0.0588Female Sterilization      0.5      0.5100Male Sterilization         0.15        0.10100

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA070687
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2001
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 54868-4045-0 identifies a specific commercial package of 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Necon 1/35, 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 August 10, 2001. 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: 54868404500. 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)
54868-4045-0
11-Digit CMS (5-4-2)
54868-4045-00

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