Rhuzdah Kit
NDC Package 59651-740-92

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

Rhuzdah (norethindrone and ethinyl estradiol tablet) kits is oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. This formulation utilizes a kit delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 59651-740 and is authorized under FDA application ANDA207585.

Identification & Billing

NDC Package Code
59651-740-92
Package Description
6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
59651-740
11-Digit Billing Format
59651074092
RxNorm Crosswalk
  • RxCUI: 238015 - norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 238015 - ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet
  • RxCUI: 2624207 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Rhuzdah 28 Day]
  • RxCUI: 2624207 - Rhuzdah 28 Day Pack
  • RxCUI: 748797 - inert 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Rhuzdah
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol Tablet
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Oral contraceptives 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 1 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 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Reproduced with permission of the Population Council from J. Trussell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.*The 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 reason other than pregnancy.**This 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 reason other than pregnancy.***Combined typical rate for both combined and progestin only.#Combined typical rate for both medicated and nonmedicated IUD. % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use MethodLowest Expected*Typical** (No contraception) Oral contraceptives     combined     progestin only Diaphragm with spermicidal cream or jelly Spermicides alone (foam, creams, jellies and vaginal suppositories) Vaginal sponge     nulliparous     multiparous IUD Condom without spermicides Periodic abstinence (all methods) Injectable progestogen Implants     6 capsules     2 rods Female sterilization Male sterilization(85) 0.10.563 690.8 to 221 to 90.3 to 0.4 0.040.030.20.1(85) 3***3***1821 18283#12200.3 to 0.4 0.040.030.40.15

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207585
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-11-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 (59651-740). Click a package code to view its specific billing and regulatory data.

59651-740-88
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 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 59651-740-92 identifies a specific commercial package of 6 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Rhuzdah, a human prescription drug labeled by Aurobindo Pharma Limited. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aurobindo Pharma Limited on October 11, 2022. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59651074092. 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)
59651-740-92
11-Digit CMS (5-4-2)
59651-0740-92

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