Nikki
NDC Package 57297-886-13

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 discontinued by the firm.

Nikki is a medication a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). Marketed by Lupin Limited, this product is identified by NDC 57297-886 and is authorized under FDA application ANDA201661.

Identification & Billing

NDC Package Code
57297-886-13
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (57297-886-11)
Product Code
57297-886
11-Digit Billing Format
57297088613

Clinical Specifications

Proprietary Name
Nikki
Dosage Form
-
Usage Information
This medication is a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). This product is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also may be used to treat premenstrual dysphoric disorder (PMDD) or moderate acne if you have chosen to use birth control pills as your method of pregnancy prevention. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Lupin Limited
FDA Application #
ANDA201661
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2014
End Marketing Date
05-31-2021
Listing Expiration
05-31-2021
Exclude Flag
D
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 57297-886-13 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack (57297-886-11) of Nikki, labeled by Lupin Limited. 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 Lupin Limited on July 24, 2014. The current certification is valid through May 31, 2021.

What are the primary indications for this medication?

This medication is a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). This product is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also may be used to treat premenstrual dysphoric disorder (PMDD) or moderate acne if you have chosen to use birth control pills as your method of pregnancy prevention. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Lupin Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57297088613. 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)
57297-886-13
11-Digit CMS (5-4-2)
57297-0886-13

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