Lutera Kit
NDC Package 55741-005-06

11-digit billing NDC: 55741000506 · Billing unit: EA · 6 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lutera (levonorgestrel and ethinyl estradiol) kits is lutera is indicated for use by females of reproductive potential to prevent pregnancy.Limitations of use: The efficacy of Lutera in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated.In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This formulation utilizes a kit delivery system. Marketed by Dr. Reddy�s Laboratories Inc., this product is identified by NDC 55741-005 and is authorized under FDA application ANDA090721.

Identification & Billing

NDC Package Code
55741-005-06
Package Description
6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
55741-005
11-Digit Billing Format
55741000506
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk
  • RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748868 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Lutera
Non-Proprietary Name
Levonorgestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Lutera is indicated for use by females of reproductive potential to prevent pregnancy.Limitations of use: The efficacy of Lutera in women with a body mass index (BMI) of > 35 kg/m2 has not been adequately evaluated.In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.The mean BMI of the study population was 24 kg/m2. Females with a BMI greater than 30 kg/m2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m2 accounted for 4.3% (n=63) of the study population.

Regulatory & Marketing

Labeler Name
Dr. Reddy�s Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090721
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2026
Listing Expiration
12-31-2027
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 (55741-005). Click a package code to view its specific billing and regulatory data.

55741-005-28
1 BLISTER PACK in 1 PACKET / 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 55741-005-06 identifies a specific commercial package of 6 blister pack in 1 carton / 1 kit in 1 blister pack of Lutera, a human prescription drug labeled by Dr. Reddy�s Laboratories Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. 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 Dr. Reddy�s Laboratories Inc. on February 13, 2026. The current certification is valid through December 31, 2027.

How is this Dr. Reddy�s Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55741000506. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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)
55741-005-06
11-Digit CMS (5-4-2)
55741-0005-06

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