Morphine Sulfate NDC 0121-4955

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-4955Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-4955Add 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
0121-4955-94	00121495594	3 TRAY in 1 CASE (0121-4955-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4955-05)Marketed from Sep 15, 2025

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 — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206573
Marketing start: Sep 15, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0121-4955_8a1bb0fe-ab24-4c30-b843-d06c61fcf0cbSPL ID 8a1bb0fe-ab24-4c30-b843-d06c61fcf0cbSPL set ID 9405556c-20e0-4e47-b1b0-7872bcc6517eRxCUI 892589UNII X3P646A2J0
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

N400121495594 followed by a unit qualifier and the quantity

Package 00121-4955-94. 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 Jan 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Oral Solution is an opioid agonist. Morphine Sulfate 2 mg/mL is indicated for the management of: adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Morphine Sulfate Oral Solution 20 mg/mL is indicated for: use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. ( 1 ) Limitations of Use : Because of the risks of a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206573

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

FDA NDC Directory listings under ANDA 206573
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	American Health Packaging	60687-927