Prepidil Gel
NDC Package 0009-3359-01

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

Prepidil (dinoprostone) gel is a medication used to help prepare your cervix (the lower opening of the womb) for labor and delivery. This formulation utilizes a gel delivery system. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-3359 and is authorized under FDA application NDA019617.

Identification & Billing

NDC Package Code
0009-3359-01
Package Description
1 SYRINGE in 1 CARTON / 3 g in 1 SYRINGE
Product Code
0009-3359
11-Digit Billing Format
00009335901
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
3 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prepidil
Non-Proprietary Name
Dinoprostone
Substance Name
Dinoprostone
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
DINOPROSTONE .5 mg/3g
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 by 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
Pharmacia & Upjohn Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019617
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-09-1992
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0009-3359). Click a package code to view its specific billing and regulatory data.

0009-3359-02
5 CARTON in 1 PACKAGE / 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE

* 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 0009-3359-01 identifies a specific commercial package of 1 syringe in 1 carton / 3 g in 1 syringe of Prepidil, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. This product is billed per "GM" gram and contains an estimated amount of 3 billable units per package. This gel 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 Pharmacia & Upjohn Company Llc on December 09, 1992. 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 by 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 Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009335901. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 3 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 (4-4-2)
0009-3359-01
11-Digit CMS (5-4-2)
00009-3359-01

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