Morphine Sulfate NDC 75826-131

NDC codes

FDA NDC Directory

Product NDC (as listed)75826-131Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75826-0131Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
75826-131-01	75826013101	30 mL in 1 BOTTLE, PLASTIC (75826-131-01)Marketed from Mar 1, 2022
75826-131-04	75826013104	120 mL in 1 BOTTLE, PLASTIC (75826-131-04)Marketed from May 15, 2019
75826-131-15	75826013115	15 mL in 1 BOTTLE, PLASTIC (75826-131-15)Marketed from May 15, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Morphine Sulfate
Generic name (nonproprietary): morphine sulfate
Active ingredients: Morphine sulfate — 100 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Winder Laboratories LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211454
Marketing start: May 15, 2019
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 75826-131_2b0eba4c-7f43-72ef-e063-6294a90afd7eSPL ID 2b0eba4c-7f43-72ef-e063-6294a90afd7eSPL set ID e9a7319a-bf1f-48db-a71e-6d4e6ead9555RxCUI 892589, 892625, 894780UNII X3P646A2J0UPC 0375826130058, 0375826131154, 0375826129052
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N475826013101 followed by a unit qualifier and the quantity

Package 75826-0131-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 28, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: adults with acute and chronic 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 the relief of acute and chronic pain in opioid-tolerant adult patients . Morphine Sulfate Oral Solution is an opioid agonist. Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Morphine Sulfate Oral Solution 20 mg/mL is indicated for: the relief of acute and chr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211454

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211454
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	Winder Laboratories LLC	75826-129
Morphine Sulfate	Morphine sulfate 20 mg/5mL	SolutionOral	Winder Laboratories LLC	75826-130