Glycerol-saline Control Injection
NDC Package 49643-818-50

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

Glycerol-saline Control (glycerol-saline diluent) injection is a medication used to relieve occasional constipation. This formulation utilizes a injection delivery system. Marketed by Allermed Laboratories, Inc., this product is identified by NDC 49643-818 and is authorized under FDA application BLA102211.

Identification & Billing

NDC Package Code
49643-818-50
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
49643-818
11-Digit Billing Format
49643081850
RxNorm Crosswalk
  • RxCUI: 1011991 - Trichothecium roseum allergenic extract 100 MG/mL Injectable Solution
  • RxCUI: 1011991 - Trichothecium roseum allergenic extract 100 MG/ML Injectable Solution
  • RxCUI: 1011991 - Trichothecium roseum extract 0.1 GM/ML Injectable Solution
  • RxCUI: 1011991 - Trichothecium roseum extract 100 MG/ML Injectable Solution
  • RxCUI: 1115265 - bluegum eucalyptus pollen extract 50 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Glycerol-saline Control
Non-Proprietary Name
Glycerol-saline Diluent
Substance Name
Glycerin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Cutaneous - Administration to the skin.
  • Intradermal - Administration within the dermis.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GLYCERIN .53 g/mL
Pharmacologic Class
Usage Information
This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

Regulatory & Marketing

Labeler Name
Allermed Laboratories, Inc.
Product Type
Non-standardized Allergenic
FDA Application #
BLA102211
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-12-1974
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49643-818). Click a package code to view its specific billing and regulatory data.

49643-818-05
5 mL in 1 VIAL, MULTI-DOSE
49643-818-10
10 mL in 1 VIAL, MULTI-DOSE
49643-818-30
30 mL in 1 VIAL, MULTI-DOSE

* 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 49643-818-50 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Glycerol-saline Control, a non-standardized allergenic label labeled by Allermed Laboratories, Inc.. This injection is formulated for cutaneous; intradermal; subcutaneous use and contains glycerin 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 Allermed Laboratories, Inc. on March 12, 1974. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

How is this Allermed Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49643081850. 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)
49643-818-50
11-Digit CMS (5-4-2)
49643-0818-50

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