Signature Care Anti Diarrheal
NDC Package 21130-440-34

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.

Signature Care Anti Diarrheal is •drink plenty of clear fluids to help prevent dehydration caused by diarrhea•find right dose on chart. Marketed by Safeway, this product is identified by NDC 21130-440 and is authorized under FDA application ANDA091292.

Identification & Billing

NDC Package Code
21130-440-34
Package Description
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
Product Code
21130-440
11-Digit Billing Format
21130044034

Clinical Specifications

Proprietary Name
Signature Care Anti Diarrheal
Dosage Form
-
Usage Information
•drink plenty of clear fluids to help prevent dehydration caused by diarrhea•find right dose on chart. If possible, use weight to dose; otherwise use age.•shake well before using•use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.•mL = milliliteradults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hourschildren 9-11 years (60-95 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hourschildren 6-8 years (48-59 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hourschildren 2-5 years(34 to 47 lbs)ask a doctorchildren under 2 years(up to 33 lbs)do not use

Regulatory & Marketing

Labeler Name
Safeway
FDA Application #
ANDA091292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-12-2018
End Marketing Date
02-28-2026
Listing Expiration
02-28-2026
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 21130-440-34 identifies a specific commercial package of 1 bottle in 1 carton / 240 ml in 1 bottle of Signature Care Anti Diarrheal, labeled by Safeway. 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 Safeway on July 12, 2018. The current certification is valid through February 28, 2026.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130044034. 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)
21130-440-34
11-Digit CMS (5-4-2)
21130-0440-34

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