Progesterone Insert
NDC Package 70095-136-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Progesterone inserts is progesterone is a type of female hormone (progestin). This formulation utilizes a insert delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 70095-136 and is authorized under FDA application NDA022057.

Identification & Billing

NDC Package Code
70095-136-03
Package Description
1 CARTON in 1 CARTON / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01)
Product Code
70095-136
11-Digit Billing Format
70095013603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Progesterone
Non-Proprietary Name
Progesterone
Substance Name
Progesterone
Dosage Form
Insert - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
PROGESTERONE 100 mg/1
Pharmacologic Class
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022057
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-27-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70095-136-03 identifies a specific commercial package of 1 carton in 1 carton / 21 blister pack in 1 carton (70095-136-02) / 1 insert in 1 blister pack (70095-136-01) of Progesterone, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This insert is formulated for vaginal use and contains progesterone 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 Sun Pharmaceutical Industries, Inc. on April 27, 2026. The current certification is valid through December 31, 2027.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70095013603. 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)
70095-136-03
11-Digit CMS (5-4-2)
70095-0136-03

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