Pitocin Injection
NDC Package 42023-130-06

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

Package Information

Pitocin (oxytocin) injection is antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion;In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;In fetal distress where delivery is not imminent;Where adequate uterine activity fails to achieve satisfactory progress;Where the uterus is already hyperactive or hypertonic;In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord;In patients with hypersensitivity to the drug. This formulation utilizes a injection delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 42023-130 and is authorized under FDA application NDA018261.

Identification & Billing

NDC Package Code
42023-130-06
Package Description
6 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
42023-130
11-Digit Billing Format
42023013006
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pitocin
Non-Proprietary Name
Oxytocin
Substance Name
Oxytocin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
OXYTOCIN 10 [iU]/mL
Pharmacologic Class
Usage Information
Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion;In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;In fetal distress where delivery is not imminent;Where adequate uterine activity fails to achieve satisfactory progress;Where the uterus is already hyperactive or hypertonic;In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord;In patients with hypersensitivity to the drug.

Regulatory & Marketing

Labeler Name
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018261
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2018
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42023-130-06 identifies a specific commercial package of 6 vial in 1 carton / 50 ml in 1 vial of Pitocin, a human prescription drug labeled by Par Health Usa, Llc. This injection is formulated for intravenous use and contains oxytocin 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 Par Health Usa, Llc on May 01, 2018. The current certification is valid through December 31, 2027.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023013006. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
42023-130-06
11-Digit CMS (5-4-2)
42023-0130-06

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