Morphine Sulfate NDC 0054-0235

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0235Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0235Add 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
0054-0235-24	00054023524	100 BLISTER PACK in 1 CARTON (0054-0235-24) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 17, 2008
0054-0235-25	00054023525	100 TABLET in 1 BOTTLE (0054-0235-25)Marketed from Mar 17, 2008

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
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022207
Marketing start: Mar 17, 2008
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0235_c89c4f71-eab3-4b74-b098-fcd31d5aa0ddSPL ID c89c4f71-eab3-4b74-b098-fcd31d5aa0ddSPL set ID 3c847554-3b4b-4d24-a145-2ef7e9b83699RxCUI 892582, 892672UNII X3P646A2J0UPC 0300540236250, 0300540235253
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

N400054023524 followed by a unit qualifier and the quantity

Package 00054-0235-24. 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 3, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Tablets are indicated for the management of: • adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 Tablets for use in patients for whom alternative treatment options …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022207

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

FDA NDC Directory listings under NDA 022207
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 30 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0236