What is NDC 0115-1279?

0115-1279 is the product NDC for Morphine Sulfate, Morphine sulfate 50 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Morphine Sulfate?

126 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Morphine Sulfate NDC 0115-1279 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1279Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1279Add 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
0115-1279-01	0011512790100115127901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-01)Marketed from Apr 12, 2016
0115-1279-03	0011512790300115127903	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-03)Marketed from Apr 12, 2016
0115-1279-08	0011512790800115127908	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-08)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 — 50 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
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 0115-1279_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

N400115127901 followed by a unit qualifier and the quantity

Package 00115-1279-01. 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)

About NDC 0115-1279

What is NDC 0115-1279?: 0115-1279 is the product NDC for Morphine Sulfate, Morphine sulfate 50 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Morphine Sulfate.
What is the active ingredient?: Morphine sulfate.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Morphine Sulfate?: 126 other product NDCs are listed under this name. See all Morphine Sulfate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Morphine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Morphine Sulfate	Morphine sulfate 15 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-893	60760-0893-60
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-110	68000-0110-01
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-111	68000-0111-05
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-112	68000-0112-05
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-113	68000-0113-03
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-114	68000-0114-03
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	American Health Packaging	60687-927	60687-0927-86
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4955	00121-4955-94
Morphine Sulfate	Morphine sulfate 100 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-556	68094-0556-58
Morphine Sulfate	Morphine sulfate 100 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-156	68094-0156-58

All 127 Morphine Sulfate NDCs

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 60 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1280
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