Orphenadrine Citrate Injection
NDC Package 0591-3222-47

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

Package Information

Orphenadrine Citrate injection is orphenadrine is used to treat muscle spasms/pain. This formulation utilizes a injection delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-3222 and is authorized under FDA application ANDA084779.

Identification & Billing

NDC Package Code
0591-3222-47
Package Description
10 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (0591-3222-02)
Product Code
0591-3222
11-Digit Billing Format
00591322247
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orphenadrine Citrate
Non-Proprietary Name
Orphenadrine Citrate
Substance Name
Orphenadrine Citrate
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)
ORPHENADRINE CITRATE 30 mg/mL
Pharmacologic Class
Usage Information
Orphenadrine is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA084779
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2010
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.

* 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 0591-3222-47 identifies a specific commercial package of 10 ampule in 1 carton / 2 ml in 1 ampule (0591-3222-02) of Orphenadrine Citrate, a human prescription drug labeled by Actavis Pharma, Inc.. This injection is formulated for intramuscular; intravenous use and contains orphenadrine citrate 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 Actavis Pharma, Inc. on July 08, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Orphenadrine is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591322247. 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:

10-Digit Format (4-4-2)
0591-3222-47
11-Digit CMS (5-4-2)
00591-3222-47

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