Cimetidine
NDC Package 0409-7445-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Cimetidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. Marketed by Hospira, Inc., this product is identified by NDC 0409-7445 and is authorized under FDA application ANDA074345.

Identification & Billing

NDC Package Code
0409-7445-01
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 8 mL in 1 VIAL, MULTI-DOSE
Product Code
0409-7445
11-Digit Billing Format
00409744501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cimetidine
Dosage Form
-
Usage Information
Cimetidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (acid reflux disease/GERD). Decreasing extra stomach acid can help relieve symptoms such as stomach pain, heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). Cimetidine belongs to a class of drugs commonly called H2 blockers. It works by reducing the amount of acid in your stomach. This medication is also available without a prescription. It is used to treat occasional heartburn caused by too much acid in the stomach (also called acid indigestion or sour stomach). It is also used to prevent heartburn and acid indigestion caused by certain foods and beverages. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

Regulatory & Marketing

Labeler Name
Hospira, Inc.
FDA Application #
ANDA074345
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-1995
End Marketing Date
09-01-2010
Listing Expiration
09-01-2010
Exclude Flag
D
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 0409-7445-01 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 8 ml in 1 vial, multi-dose of Cimetidine, labeled by Hospira, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hospira, Inc. on January 31, 1995. The current certification is valid through September 01, 2010.

What are the primary indications for this medication?

Cimetidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (acid reflux disease/GERD). Decreasing extra stomach acid can help relieve symptoms such as stomach pain, heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). Cimetidine belongs to a class of drugs commonly called H2 blockers. It works by reducing the amount of acid in your stomach. This medication is also available without a prescription. It is used to treat occasional heartburn caused by too much acid in the stomach (also called acid indigestion or sour stomach). It is also used to prevent heartburn and acid indigestion caused by certain foods and beverages. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00409744501. 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)
0409-7445-01
11-Digit CMS (5-4-2)
00409-7445-01

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