Progesterone Vaginal Insert
NDC Package 70700-201-70

11-digit billing NDC: 70700020170 · Billing unit: EA · 21 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Progesterone Vaginal Insert (progesterone) inserts is progesterone vaginal insert is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks. This formulation utilizes a insert delivery system. Marketed by Xiromed, Llc, this product is identified by NDC 70700-201 and is authorized under FDA application ANDA218391.

Identification & Billing

NDC Package Code
70700-201-70
Package Description
1 CARTON in 1 CARTON / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68)
Product Code
70700-201
11-Digit Billing Format
70700020170
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
21 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Progesterone Vaginal Insert
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 vaginal insert is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.

Regulatory & Marketing

Labeler Name
Xiromed, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218391
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2025
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 70700-201-70 identifies a specific commercial package of 1 carton in 1 carton / 21 blister pack in 1 carton (70700-201-69) / 1 insert in 1 blister pack (70700-201-68) of Progesterone Vaginal Insert, a human prescription drug labeled by Xiromed, Llc. 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 Xiromed, Llc on September 23, 2025. The current certification is valid through December 31, 2027.

How is this Xiromed, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700020170. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 21 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)
70700-201-70
11-Digit CMS (5-4-2)
70700-0201-70

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