Morphine Sulfate NDC 0115-1280

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1280Add 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
0115-1280-01	00115128001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1280-01)Marketed from Apr 12, 2016
0115-1280-03	00115128003	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1280-03)Marketed from Apr 12, 2016
0115-1280-08	00115128008	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1280-08)Marketed from Apr 12, 2016

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 — 60 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200411
Marketing start: Apr 12, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0115-1280_b2330bfc-8b32-421e-ade5-2076ee23cebbSPL ID b2330bfc-8b32-421e-ade5-2076ee23cebbSPL set ID f7e9a4b3-a2ee-4f0a-becd-6ef90867332bRxCUI 892345, 892352, 892554, 892596, 894801, 894814, 1303736UNII X3P646A2J0UPC 0301151281011, 0301151280014
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

N400115128001 followed by a unit qualifier and the quantity

Package 00115-1280-01. 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 Nov 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine sulfate extended-release capsules 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 (5.1) ], reserve opioid analgesics, including morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. M…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200411

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

FDA NDC Directory listings under ANDA 200411
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 20 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1277
Morphine Sulfate	Morphine sulfate 30 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1278
Morphine Sulfate	Morphine sulfate 50 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1279
Morphine Sulfate	Morphine sulfate 80 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1281
Morphine Sulfate	Morphine sulfate 100 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1282
Morphine Sulfate	Morphine sulfate 40 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1479