Sucralfate Suspension
NDC Package 66689-305-16

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

Package Information

Sucralfate suspension is a medication used to treat and prevent ulcers in the intestines. This formulation utilizes a suspension delivery system. Marketed by Vistapharm, Llc, this product is identified by NDC 66689-305 and is authorized under FDA application ANDA211884.

Identification & Billing

NDC Package Code
66689-305-16
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 414 mL in 1 BOTTLE, PLASTIC
Product Code
66689-305
11-Digit Billing Format
66689030516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sucralfate
Non-Proprietary Name
Sucralfate
Substance Name
Sucralfate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SUCRALFATE 1 g/10mL
Pharmacologic Class
Usage Information
This medication is used to treat and prevent ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly.

Regulatory & Marketing

Labeler Name
Vistapharm, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211884
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-15-2022
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66689-305-16 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 414 ml in 1 bottle, plastic of Sucralfate, a human prescription drug labeled by Vistapharm, Llc. This suspension is formulated for oral use and contains sucralfate 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 Vistapharm, Llc on March 15, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly.

How is this Vistapharm, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66689030516. 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 (5-3-2)
66689-305-16
11-Digit CMS (5-4-2)
66689-0305-16

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