Oxytocin Injection
NDC Package 0143-9743-25

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

Package Information

Oxytocin injection is (synthetic) is contraindicated in any of the following conditions: Significant cephalopelvic disproportion;  Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies;  In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;  In cases of fetal distress where delivery is not imminent;  Prolonged use in uterine inertia or severe toxemia;  Hypertonic uterine patterns;  Patients with hypersensitivity to the drug;  Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa. This formulation utilizes a injection delivery system. Marketed by West-ward Pharmaceuticals Corp, this product is identified by NDC 0143-9743 and is authorized under FDA application ANDA200219.

Identification & Billing

NDC Package Code
0143-9743-25
Package Description
25 VIAL in 1 CARTON / 1 mL in 1 VIAL (0143-9743-01)
Product Code
0143-9743
11-Digit Billing Format
00143974325
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxytocin
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
OXYTOCIN 10 [USP'U]/mL
Pharmacologic Class
Usage Information
Oxytocin injection (synthetic) is contraindicated in any of the following conditions: Significant cephalopelvic disproportion;  Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies;  In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;  In cases of fetal distress where delivery is not imminent;  Prolonged use in uterine inertia or severe toxemia;  Hypertonic uterine patterns;  Patients with hypersensitivity to the drug;  Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.

Regulatory & Marketing

Labeler Name
West-ward Pharmaceuticals Corp
Product Type
Human Prescription Drug
FDA Application #
ANDA200219
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2013
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0143-9743-25 identifies a specific commercial package of 25 vial in 1 carton / 1 ml in 1 vial (0143-9743-01) of Oxytocin, a human prescription drug labeled by West-ward Pharmaceuticals Corp. This injection is formulated for intramuscular; 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 West-ward Pharmaceuticals Corp on February 13, 2013. The current certification is valid through December 31, 2026.

How is this West-ward Pharmaceuticals Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143974325. 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)
0143-9743-25
11-Digit CMS (5-4-2)
00143-9743-25

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