NDC Package 0009-3359-02 Prepidil

Dinoprostone Gel Vaginal - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0009-3359-02

Package Description:

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

Product Code:

0009-3359

Proprietary Name:

Prepidil

Non-Proprietary Name:

Dinoprostone

Substance Name:

Dinoprostone

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.

11-Digit NDC Billing Format:

00009335902

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

3 GM

NDC to RxNorm Crosswalk:

RxCUI: 208397 - Prepidil 0.5 MG per 3 GM Vaginal Gel
RxCUI: 208397 - dinoprostone 0.000167 MG/MG Vaginal Gel [Prepidil]
RxCUI: 208397 - PGE2 0.000167 MG/MG Vaginal Gel [Prepidil]
RxCUI: 208397 - Prepidil 0.000167 MG/MG Vaginal Gel
RxCUI: 309922 - dinoprostone 0.5 MG per 3 GM Vaginal Gel

Product Type:

Human Prescription Drug

Labeler Name:

Pharmacia & Upjohn Company Llc

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(s):

Vaginal - Administration into the vagina.

Active Ingredient(s):

DINOPROSTONE .5 mg/3g

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

NDA019617

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

12-09-1992

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

0009 - Pharmacia & Upjohn Company Llc
- 0009-3359 - Prepidil
  - 0009-3359-02 - 5 CARTON in 1 PACKAGE / 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0009-3359-01	1 SYRINGE in 1 CARTON / 3 g in 1 SYRINGE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0009-3359-02?

The NDC Packaged Code 0009-3359-02 is assigned to a package of 5 carton in 1 package / 1 syringe in 1 carton (0009-3359-01) / 3 g in 1 syringe of Prepidil, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. The product's dosage form is gel and is administered via vaginal form.This product is billed per "GM" gram and contains an estimated amount of 3 billable units per package.

Is NDC 0009-3359 included in the NDC Directory?

Yes, Prepidil with product code 0009-3359 is active and included in the NDC Directory. The product was first marketed by Pharmacia & Upjohn Company Llc on December 09, 1992 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0009-3359-02?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 3.

What is the 11-digit format for NDC 0009-3359-02?

The 11-digit format is 00009335902. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0009-3359-02	5-4-2	00009-3359-02

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