Progesterone
NDC Package 70934-535-10

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Progesterone is a type of female hormone (progestin). Marketed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals, this product is identified by NDC 70934-535 and is authorized under FDA application ANDA211285.

Identification & Billing

NDC Package Code
70934-535-10
Package Description
10 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
70934-535
11-Digit Billing Format
70934053510
RxNorm Crosswalk
RxCUI: 260243 - progesterone 100 MG Oral Capsule

Clinical Specifications

Proprietary Name
Progesterone
Dosage Form
-
Usage Information
Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

Regulatory & Marketing

Labeler Name
Denton Pharma, Inc. Dba Northwind Pharmaceuticals
FDA Application #
ANDA211285
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2020
Listing Expiration
12-31-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70934-535). Click a package code to view its specific billing and regulatory data.

70934-535-30
30 CAPSULE in 1 BOTTLE, PLASTIC

* 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 70934-535-10 identifies a specific commercial package of 10 capsule in 1 bottle, plastic of Progesterone, labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. 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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals on February 12, 2020. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.

How is this Denton Pharma, Inc. Dba Northwind Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70934053510. 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)
70934-535-10
11-Digit CMS (5-4-2)
70934-0535-10

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