Oxytocin Injection, Solution
NDC Package 65219-021-01
Package Information
Oxytocin injection is IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-021 and is authorized under FDA application NDA018248.
Identification & Billing
- RxCUI: 1791721 - oxytocin 10 UNT in 1 ML Injection
- RxCUI: 1791721 - 1 ML oxytocin 10 UNT/ML Injection
- RxCUI: 1791721 - oxytocin 10 UNT per 1 ML Injection
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 65219 - Fresenius Kabi Usa, Llc
- 65219-021 - Oxytocin
- 65219-021-01 - 25 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)
- 65219-021 - Oxytocin
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 65219-021-01 identifies a specific commercial package of 25 vial, single-dose in 1 tray / 1 ml in 1 vial, single-dose (65219-021-00) of Oxytocin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution 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 Fresenius Kabi Usa, Llc on May 06, 2024. The current certification is valid through December 31, 2026.
How is this Fresenius Kabi Usa, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219002101. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
