Morphine Sulfate Solution
NDC Package 68000-110-01

11-digit billing NDC: 68000011001
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Morphine Sulfate solution is morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of:adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Morphine Sulfate Oral Solution 20 mg/mL is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [seeWarnings and Precautions (5.2)], reserve opioid analgesics, including Morphine Sulfate Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. This formulation utilizes a solution delivery system. Marketed by American Health Packaging, this product is identified by NDC 68000-110 and is authorized under FDA application ANDA203518.

Identification & Billing

NDC Package Code
68000-110-01
Package Description
10 SYRINGE in 1 CARTON / .125 mL in 1 SYRINGE (68000-110-06)
Product Code
68000-110
11-Digit Billing Format
68000011001
RxNorm Crosswalk
  • RxCUI: 892625 - morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 892625 - morphine sulfate 20 MG/ML Oral Solution
  • RxCUI: 892625 - morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution
  • RxCUI: 892625 - morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution
  • RxCUI: 892625 - morphine sulfate 20 MG/ML Concentrate for Oral Solution

Clinical Specifications

Proprietary Name
Morphine Sulfate
Non-Proprietary Name
Morphine Sulfate
Substance Name
Morphine Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MORPHINE SULFATE 20 mg/mL
Pharmacologic Class
Usage Information
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of:adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Morphine Sulfate Oral Solution 20 mg/mL is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [seeWarnings and Precautions (5.2)], reserve opioid analgesics, including Morphine Sulfate Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain .
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA203518
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2026
Listing Expiration
12-31-2027
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 68000-110-01 identifies a specific commercial package of 10 syringe in 1 carton / .125 ml in 1 syringe (68000-110-06) of Morphine Sulfate, a human prescription drug labeled by American Health Packaging. This solution is formulated for oral use and contains morphine sulfate 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 American Health Packaging on May 01, 2026. The current certification is valid through December 31, 2027.

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68000011001. 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)
68000-110-01
11-Digit CMS (5-4-2)
68000-0110-01

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