Dopram Injection
NDC Package 0641-6018-06

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

Package Information

Dopram (doxapram hydrochloride) injection is doxapram is contraindicated in patients with known hypersensitivity to the drug or any of the injection components.Doxapram should not be used in patients with epilepsy or other convulsive disorders.Doxapram is contraindicated in patients with proven or suspected pulmonary embolism.Doxapram is contraindicated in patients with mechanical disorders of ventilation such as mechanical obstruction, muscle paresis (including neuromuscular blockade), flail chest, pneumothorax, acute bronchial asthma, pulmonary fibrosis, or other conditions resulting in restriction of the chest wall, muscles of respiration, or alveolar expansion.Doxapram is contraindicated in patients with evidence of head injury, cerebral vascular accident, or cerebral edema, and in those with significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, or severe hypertension, including that associated with hyperthyroidism or pheochromocytoma. This formulation utilizes a injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6018 and is authorized under FDA application NDA014879.

Identification & Billing

NDC Package Code
0641-6018-06
Package Description
6 VIAL in 1 CARTON / 20 mL in 1 VIAL (0641-6018-01)
Product Code
0641-6018
11-Digit Billing Format
00641601806
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dopram
Non-Proprietary Name
Doxapram Hydrochloride
Substance Name
Doxapram 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)
DOXAPRAM HYDROCHLORIDE 20 mg/mL
Pharmacologic Class
Usage Information
Doxapram is contraindicated in patients with known hypersensitivity to the drug or any of the injection components.Doxapram should not be used in patients with epilepsy or other convulsive disorders.Doxapram is contraindicated in patients with proven or suspected pulmonary embolism.Doxapram is contraindicated in patients with mechanical disorders of ventilation such as mechanical obstruction, muscle paresis (including neuromuscular blockade), flail chest, pneumothorax, acute bronchial asthma, pulmonary fibrosis, or other conditions resulting in restriction of the chest wall, muscles of respiration, or alveolar expansion.Doxapram is contraindicated in patients with evidence of head injury, cerebral vascular accident, or cerebral edema, and in those with significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, or severe hypertension, including that associated with hyperthyroidism or pheochromocytoma. (See WARNINGS.)

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA014879
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-23-1965
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0641-6018). Click a package code to view its specific billing and regulatory data.

0641-6018-01
20 mL in 1 VIAL

* 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 0641-6018-06 identifies a specific commercial package of 6 vial in 1 carton / 20 ml in 1 vial (0641-6018-01) of Dopram, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intravenous use and contains doxapram 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 Hikma Pharmaceuticals Usa Inc. on June 23, 1965. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641601806. 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)
0641-6018-06
11-Digit CMS (5-4-2)
00641-6018-06

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