Biorphen Injection, Solution
NDC Package 43598-199-10

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

Package Information

Biorphen (phenylephrine hydrochloride) injection is bIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. This formulation utilizes a injection, solution delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-199 and is authorized under FDA application NDA212909.

Identification & Billing

NDC Package Code
43598-199-10
Package Description
10 AMPULE in 1 CARTON / 1 mL in 1 AMPULE (43598-199-01)
Product Code
43598-199
11-Digit Billing Format
43598019910
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Biorphen
Non-Proprietary Name
Phenylephrine Hydrochloride
Substance Name
Phenylephrine Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
BIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212909
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-25-2022
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 43598-199-10 identifies a specific commercial package of 10 ampule in 1 carton / 1 ml in 1 ampule (43598-199-01) of Biorphen, a human prescription drug labeled by Dr. Reddy's Laboratories Inc.. This injection, solution 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 Dr. Reddy's Laboratories Inc. on November 25, 2022. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598019910. 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)
43598-199-10
11-Digit CMS (5-4-2)
43598-0199-10

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