Hydralazine Hydrochloride Injection
NDC Package 55154-9554-5

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

Package Information

Hydralazine Hydrochloride injection is severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure. This formulation utilizes a injection delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-9554 and is authorized under FDA application ANDA040388.

Identification & Billing

NDC Package Code
55154-9554-5
Package Description
5 VIAL, SINGLE-DOSE in 1 BAG / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
55154-9554
11-Digit Billing Format
55154955405
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydralazine Hydrochloride
Non-Proprietary Name
Hydralazine Hydrochloride
Substance Name
Hydralazine Hydrochloride
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)
HYDRALAZINE HYDROCHLORIDE 20 mg/mL
Pharmacologic Class
Usage Information
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040388
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-05-2001
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 55154-9554-5 identifies a specific commercial package of 5 vial, single-dose in 1 bag / 1 ml in 1 vial, single-dose of Hydralazine Hydrochloride, a human prescription drug labeled by Cardinal Health 107, Llc. This injection is formulated for intramuscular; intravenous use and contains hydralazine 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 Cardinal Health 107, Llc on September 05, 2001. The current certification is valid through December 31, 2027.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154955405. 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 (5-4-1)
55154-9554-5
11-Digit CMS (5-4-2)
55154-9554-05

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