Cimetidine
NDC Package 0121-0649-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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 Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0649 and is authorized under FDA application ANDA074553.

Identification & Billing

NDC Package Code
0121-0649-08
Package Description
237 mL in 1 BOTTLE
Product Code
11-Digit Billing Format
00121064908
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML

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
Pai Holdings, Llc Dba Pai Pharma
FDA Application #
ANDA074553
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2021
End Marketing Date
10-31-2022
Listing Expiration
10-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0121-0649). Click a package code to view its specific billing and regulatory data.

4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0649-05)

* 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 0121-0649-08 identifies a specific commercial package of 237 ml in 1 bottle of Cimetidine, labeled by Pai Holdings, Llc Dba Pai Pharma. 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 Pai Holdings, Llc Dba Pai Pharma on February 12, 2021. The current certification is valid through October 31, 2022.

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 Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121064908. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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 (4-4-2)
0121-0649-08
11-Digit CMS (5-4-2)
00121-0649-08

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