Morphine Sulfate NDC 0406-5118

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-5118Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-5118Add 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	Copy
0406-5118-01	00406511801	100 TABLET in 1 BOTTLE (0406-5118-01)Marketed from Sep 1, 2023
0406-5118-62	00406511862	10 BLISTER PACK in 1 CARTON (0406-5118-62) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215194
Marketing start: Sep 1, 2023
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-5118_4212f903-83d4-42e3-af2a-55a6d63b5c36SPL ID 4212f903-83d4-42e3-af2a-55a6d63b5c36SPL set ID 8b69f67f-30b3-4982-953e-5a4b87ec6ac6RxCUI 892582, 892672UNII X3P646A2J0
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

N400406511801 followed by a unit qualifier and the quantity

Package 00406-5118-01. 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 Jul 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Tablets are indicated for the management of: adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative 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 [see Warnings and Precautions ( 5.1 )], reserve opioid analgesics, including morphine sulfate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215194

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

FDA NDC Directory listings under ANDA 215194
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 30 mg/1	TabletOral	SpecGx LLC	0406-5119
Morphine Sulfate	Morphine sulfate 15 mg/1	TabletOral	Redpharm Drug	67296-2122
Morphine Sulfate	Morphine sulfate 15 mg/1	TabletOral	Redpharm Drug	67296-2122