Cimetidine
NDC Package 54868-3316-3

11-digit billing NDC: 54868331603 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cimetidine is tablets are indicated in:1) Short-term treatment of active duodenal ulcer. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3316 and is authorized under FDA application ANDA074424.

Identification & Billing

NDC Package Code
54868-3316-3
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
54868-3316
11-Digit Billing Format
54868331603
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cimetidine
Dosage Form
-
Usage Information
Cimetidine tablets are indicated in:1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION, Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg at bedtime for periods of up to five years.3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than eight weeks.4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for twelve weeks for healing of lesions and control of symptoms. The use of cimetidine beyond twelve weeks has not been established (see DOSAGE AND ADMINISTRATION, GERD).5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA074424
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-23-1994
Listing Expiration
12-31-2017
Exclude Flag
I
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 (54868-3316). Click a package code to view its specific billing and regulatory data.

54868-3316-0
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-3316-2
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 54868-3316-3 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Cimetidine, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Physicians Total Care, Inc. on May 23, 1994. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868331603. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
54868-3316-3
11-Digit CMS (5-4-2)
54868-3316-03

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