Medroxyprogesterone Acetate
NDC Package 69097-539-31

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.

Medroxyprogesterone Acetate is a medication used to prevent pregnancy. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-539 and is authorized under FDA application ANDA210335.

Identification & Billing

NDC Package Code
69097-539-31
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
69097-539
11-Digit Billing Format
69097053931

Clinical Specifications

Proprietary Name
Medroxyprogesterone Acetate
Dosage Form
-
Usage Information
This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body. It works mainly by preventing the growth and 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. Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Cipla Usa Inc.
FDA Application #
ANDA210335
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-25-2019
End Marketing Date
12-15-2023
Listing Expiration
12-15-2023
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 69097-539-31 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Medroxyprogesterone Acetate, labeled by Cipla Usa Inc.. 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 Cipla Usa Inc. on January 25, 2019. The current certification is valid through December 15, 2023.

What are the primary indications for this medication?

This medication is used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body. It works mainly by preventing the growth and 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. Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097053931. 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)
69097-539-31
11-Digit CMS (5-4-2)
69097-0539-31

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