Morphine Sulfate NDC 43386-544

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0544Add 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
43386-544-01	43386054401	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-544-01)Marketed from Dec 16, 2015

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 — 200 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203602
Marketing start: Dec 16, 2015
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 43386-544_d4efe614-fe99-4cc7-b3ba-87c4e010efbdSPL ID d4efe614-fe99-4cc7-b3ba-87c4e010efbdSPL set ID d360a33f-6323-4b10-9e81-07e2813c2dbdRxCUI 891874, 891881, 891888, 891893, 892646UNII X3P646A2J0UPC 0343386542017, 0343386543014, 0343386540013, 0343386541010
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

N443386054401 followed by a unit qualifier and the quantity

Package 43386-0544-01. 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 Feb 16, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203602

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

FDA NDC Directory listings under ANDA 203602
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 100 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals,Inc.	43386-543
Morphine Sulfate	Morphine sulfate 15 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals,Inc.	43386-540
Morphine Sulfate	Morphine sulfate 30 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals,Inc.	43386-541
Morphine Sulfate	Morphine sulfate 60 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals,Inc.	43386-542