Megestrol Acetate Suspension
NDC Package 0116-4011-40

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

Megestrol Acetate suspension is megestrol is used to treat loss of appetite and weight loss in people with AIDS. This formulation utilizes a suspension delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-4011 and is authorized under FDA application ANDA076721.

Identification & Billing

NDC Package Code
0116-4011-40
Package Description
40 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)
Product Code
0116-4011
11-Digit Billing Format
00116401140
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Megestrol Acetate
Non-Proprietary Name
Megestrol Acetate
Substance Name
Megestrol Acetate
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)
MEGESTROL ACETATE 40 mg/mL
Pharmacologic Class
Usage Information
Megestrol is used to treat loss of appetite and weight loss in people with AIDS. Improving your appetite and gaining weight may help you feel better and be more active. Megestrol is similar to a natural substance made by the body called progesterone.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076721
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2025
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 (0116-4011). Click a package code to view its specific billing and regulatory data.

0116-4011-08
237 mL in 1 BOTTLE, PLASTIC
0116-4011-11
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)
0116-4011-16
480 mL in 1 BOTTLE, PLASTIC
0116-4011-30
30 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)

* 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 0116-4011-40 identifies a specific commercial package of 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose (0116-4011-10) of Megestrol Acetate, a human prescription drug labeled by Xttrium Laboratories, Inc.. This suspension is formulated for oral use and contains megestrol acetate 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 Xttrium Laboratories, Inc. on March 28, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Megestrol is used to treat loss of appetite and weight loss in people with AIDS. Improving your appetite and gaining weight may help you feel better and be more active. Megestrol is similar to a natural substance made by the body called progesterone.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116401140. 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 (4-4-2)
0116-4011-40
11-Digit CMS (5-4-2)
00116-4011-40

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