Junel Fe 1.5/30
NDC Package 42254-242-28

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.

Junel Fe 1.5/30 is junel® 21 and Junel ® Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Marketed by Rebel Distributors Corp, this product is identified by NDC 42254-242 and is authorized under FDA application ANDA076064.

Identification & Billing

NDC Package Code
42254-242-28
Package Description
1 KIT in 1 BLISTER PACK
Product Code
42254-242
11-Digit Billing Format
42254024228
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: 1359022 - norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359023 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1359023 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Junel Fe 1.5/30
Dosage Form
-
Usage Information
Junel® 21 and Junel ® Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHODAdapted from RA Hatcher et al, Reference 7.% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous UseMethodLowestExpectedThe authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.TypicalThis term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.(No contraception)(85)(85)Oral contraceptives combined progestin only0.10.53N/AN/A--Data not availableN/ADiaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)626Vaginal Sponge nulliparous parous9202040Implant0.050.05Injection: depot medroxyprogesterone acetate0.30.3IUD progesterone T copper T 380A LNg 201.50.60.12.00.80.1Condom without spermicides female male 532114Cervical Cap with spermicidal cream or jelly nulliparous parous9262040Periodic abstinence (all methods)1 to 925Withdrawal419Female sterilization0.50.5Male sterilization0.100.15

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA076064
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-21-2011
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 42254-242-28 identifies a specific commercial package of 1 kit in 1 blister pack of Junel Fe 1.5/30, 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 21, 2011. 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: 42254024228. 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)
42254-242-28
11-Digit CMS (5-4-2)
42254-0242-28

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