Magnesium Sulfate Heptahydrate Granule
NDC Package 21291-2000-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Magnesium Sulfate Heptahydrate granules is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a granule delivery system. Marketed by Premier Magnesia Llc, this product is identified by NDC 21291-2000.

Identification & Billing

NDC Package Code
21291-2000-1
Package Description
907.2 kg in 1 SUPERSACK
Product Code
21291-2000
11-Digit Billing Format
21291200001

Clinical Specifications

Proprietary Name
Magnesium Sulfate Heptahydrate
Non-Proprietary Name
Magnesium Sulfate Heptahydrate
Substance Name
Magnesium Sulfate Heptahydrate
Dosage Form
Granule - A small particle or grain.
Active Ingredient(s)
MAGNESIUM SULFATE HEPTAHYDRATE 1 kg/kg

Regulatory & Marketing

Labeler Name
Premier Magnesia Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-29-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 21291-2000-1 identifies a specific commercial package of 907.2 kg in 1 supersack of Magnesium Sulfate Heptahydrate (UNFINISHED drug), a bulk ingredient labeled by Premier Magnesia Llc. This granule is formulated for use and contains magnesium sulfate heptahydrate 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 Premier Magnesia Llc on November 29, 2022. The current certification is valid through December 31, 2026.

How is this Premier Magnesia Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21291200001. 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)
21291-2000-1
11-Digit CMS (5-4-2)
21291-2000-01

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