Necon 0.5/35
NDC Package 42254-287-28

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

Necon 0.5/35 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 Rebel Distributors Corp, this product is identified by NDC 42254-287 and is authorized under FDA application ANDA070686.

Identification & Billing

NDC Package Code
42254-287-28
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
42254-287
11-Digit Billing Format
42254028728
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 0.5/35
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 - 85 85  Spermicides5 - 26   6 40 Periodic abstinence  25  63   Calendar    9    Ovulation Method    3    Sympto-Thermal6 -    2    Post-Ovulation    1  Withdrawal  19   4  Cap7 -      Parous Women 40 26 42   Nulliparous Women  20   9 56 Sponge      Parous Women 40 20 42   Nulliparous Women  20   9 56 Diaphragm7 - 20   6 56 Condom8 -      Female (Reality) 21   5 56   Male 14   3 61 Pill   5  71   Progestin Only        0.5    Combined        0.1  IUD      Progesterone T       2.0       1.5 81   Copper T380A       0.8       0.6 78   LNg 20       0.1       0.1 81 Depo–Provera       0.3       0.3 70 Norplant and Norplant-2         0.05         0.05 88 Female Sterilization       0.5       0.5 100 Male Sterilization          0.15         0.10 100

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA070686
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-1987
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42254-287). Click a package code to view its specific billing and regulatory data.

42254-287-03
3 BLISTER PACK in 1 CARTON / 1 KIT 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 42254-287-28 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Necon 0.5/35, labeled by Rebel Distributors Corp. 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 Rebel Distributors Corp on January 29, 1987. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42254028728. 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 (5-3-2)
42254-287-28
11-Digit CMS (5-4-2)
42254-0287-28

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