Cervidil Insert
NDC Package 55566-2800-1

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

Package Information

Cervidil (dinoprostone) inserts is a medication used to help prepare your cervix (the lower opening of the womb) for labor and delivery. This formulation utilizes a insert delivery system. Marketed by Ferring Pharmaceuticals Inc., this product is identified by NDC 55566-2800 and is authorized under FDA application NDA020411.

Identification & Billing

NDC Package Code
55566-2800-1
Package Description
1 POUCH in 1 CARTON / 10 mg in 1 POUCH (55566-2800-0)
Product Code
55566-2800
11-Digit Billing Format
55566280001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cervidil
Non-Proprietary Name
Dinoprostone
Substance Name
Dinoprostone
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)
DINOPROSTONE 10 mg/241mg
Pharmacologic Class
Usage Information
This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used in women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

Regulatory & Marketing

Labeler Name
Ferring Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020411
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-30-1995
Listing Expiration
12-31-2026
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 55566-2800-1 identifies a specific commercial package of 1 pouch in 1 carton / 10 mg in 1 pouch (55566-2800-0) of Cervidil, a human prescription drug labeled by Ferring Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This insert is formulated for vaginal use and contains dinoprostone 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 Ferring Pharmaceuticals Inc. on March 30, 1995. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to help prepare your cervix (the lower opening of the womb) for labor and delivery. It is used in women who are having a normal pregnancy and who are at or near their delivery due date. Dinoprostone is a natural substance that your body makes in preparation for labor. It relaxes and softens your cervix (cervical ripening) to allow the baby to pass through the birth canal during delivery.

How is this Ferring Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55566280001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
55566-2800-1
11-Digit CMS (5-4-2)
55566-2800-01

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