Morphine Sulfate NDC 42689-005

NDC codes

FDA NDC Directory

Product NDC (as listed)42689-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42689-0005Add 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
42689-005-01	42689000501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01)Marketed from Apr 7, 2009

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 — 20 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Nortec Development Associates, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203158
Marketing start: Apr 7, 2009
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 42689-005_863bb977-9d7b-4258-a6ff-3ed2eeefeb81SPL ID 863bb977-9d7b-4258-a6ff-3ed2eeefeb81SPL set ID 9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4RxCUI 892345, 892352, 892554, 892596, 894801, 894814UNII X3P646A2J0UPC 0342689009012, 0342689008015, 0342689007018, 0342689010018
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

N442689000501 followed by a unit qualifier and the quantity

Package 42689-0005-01. 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 25, 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. Morphine Sulfate Extended-Release Capsules is 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. ( 1 ) 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) ] , …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203158

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

FDA NDC Directory listings under ANDA 203158
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 60 mg/1	Capsule, Extended releaseOral	Nortec Development Associates, Inc.	42689-008
Morphine Sulfate	Morphine sulfate 30 mg/1	Capsule, Extended releaseOral	Nortec Development Associates, Inc.	42689-006
Morphine Sulfate	Morphine sulfate 50 mg/1	Capsule, Extended releaseOral	Nortec Development Associates, Inc.	42689-007
Morphine Sulfate	Morphine sulfate 80 mg/1	Capsule, Extended releaseOral	Nortec Development Associates, Inc.	42689-009
Morphine Sulfate	Morphine sulfate 100 mg/1	Capsule, Extended releaseOral	Nortec Development Associates, Inc.	42689-010