Morphine Sulfate NDC 0406-8315

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-8315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-8315Add 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
0406-8315-01	00406831501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8315-01)Marketed from Jul 31, 2003
0406-8315-23	00406831523	1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-23)Marketed from Jul 31, 2003
0406-8315-62	00406831562	100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8315-62)Marketed from Jul 31, 2003

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, Extended release
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076412
Marketing start: Jul 31, 2003
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-8315_75047134-99f7-41cf-8088-88490e489074SPL ID 75047134-99f7-41cf-8088-88490e489074SPL set ID 533034fd-c8e7-495b-8874-0db41bd1e65aRxCUI 891874, 891881, 891888, 891893, 892646UNII X3P646A2J0UPC 0304068320019
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

N400406831501 followed by a unit qualifier and the quantity

Package 00406-8315-01. 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 Aug 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 ( 5.2 )] , reserve opioid analgesics, including morphine sulfate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Mo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076412

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

FDA NDC Directory listings under ANDA 076412
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 30 mg/1	Tablet, Extended releaseOral	SpecGx LLC	0406-8330
Morphine Sulfate	Morphine sulfate 60 mg/1	Tablet, Extended releaseOral	SpecGx LLC	0406-8380