Signature Care Acid Controller Tablet, Film Coated
NDC Package 21130-777-71

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Signature Care Acid Controller (famotidine) tablets is famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This formulation utilizes a tablet, film coated delivery system. Marketed by Safeway, this product is identified by NDC 21130-777 and is authorized under FDA application ANDA077351.

Identification & Billing

NDC Package Code
21130-777-71
Package Description
1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE
Product Code
21130-777
11-Digit Billing Format
21130077771

Clinical Specifications

Proprietary Name
Signature Care Acid Controller Maximum Strength
Non-Proprietary Name
Famotidine
Substance Name
Famotidine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FAMOTIDINE 20 mg/1
Pharmacologic Class
Usage Information
Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). 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.

Regulatory & Marketing

Labeler Name
Safeway
Product Type
Human Otc Drug
FDA Application #
ANDA077351
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2015
End Marketing Date
08-31-2026
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 (21130-777). Click a package code to view its specific billing and regulatory data.

21130-777-02
25 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
21130-777-82
1 BOTTLE in 1 CARTON / 200 TABLET, FILM COATED in 1 BOTTLE

* 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 21130-777-71 identifies a specific commercial package of 1 bottle in 1 carton / 50 tablet, film coated in 1 bottle of Signature Care Acid Controller Maximum Strength, a human over the counter drug labeled by Safeway. This tablet, film coated is formulated for oral use and contains famotidine 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 Safeway on September 04, 2015.

What are the primary indications for this medication?

Famotidine is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Famotidine belongs to a class of drugs known as H2 blockers. This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). 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.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130077771. 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 (5-3-2)
21130-777-71
11-Digit CMS (5-4-2)
21130-0777-71

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