Phenylephrine Hydrochloride Injection
NDC Package 58657-853-01

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

Package Information

Phenylephrine Hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. This formulation utilizes a injection delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-853 and is authorized under FDA application ANDA218412.

Identification & Billing

NDC Package Code
58657-853-01
Package Description
10 mL in 1 VIAL, PHARMACY BULK PACKAGE
Product Code
58657-853
11-Digit Billing Format
58657085301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 1232651 - phenylephrine HCl 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 1 % Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution

Clinical Specifications

Proprietary Name
Phenylephrine Hydrochloride
Non-Proprietary Name
Phenylephrine Hydrochloride
Substance Name
Phenylephrine Hydrochloride
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)
PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218412
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2026
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.

* 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 58657-853-01 identifies a specific commercial package of 10 ml in 1 vial, pharmacy bulk package of Phenylephrine Hydrochloride, a human prescription drug labeled by Method Pharmaceuticals, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This injection is formulated for intravenous use and contains phenylephrine hydrochloride 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 Method Pharmaceuticals, Llc on February 01, 2026. The current certification is valid through December 31, 2027.

How is this Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657085301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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 (5-3-2)
58657-853-01
11-Digit CMS (5-4-2)
58657-0853-01

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