Infumorph 500 (morphine sulfate) NDC 0641-6040

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6040Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6040Add 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
0641-6040-01	00641604001	20 mL in 1 AMPULE (0641-6040-01)Marketed from Sep 18, 1984

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): Infumorph 500
Generic name (nonproprietary): morphine sulfate
Active ingredients: Morphine sulfate — 25 mg/mL
Dosage form: Injection, Solution
Route: Epidural, Intrathecal
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018565
Marketing start: Sep 18, 1984
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0641-6040_b1c060cb-5c5b-495f-90b5-044e04f2a3f2SPL ID b1c060cb-5c5b-495f-90b5-044e04f2a3f2SPL set ID db9ac9e3-d761-4a99-9f34-4946ebe8f255RxCUI 892652, 1731522, 1731998, 1731999UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400641604001 followed by a unit qualifier and the quantity

Package 00641-6040-01. 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 Dec 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INFUMORPH is for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of Use Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because INFUMORPH is too concentrated for accurate delivery of the smaller doses used in this setting. INFUMORPH is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of int…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 018565

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

FDA NDC Directory listings under NDA 018565
Product	Strength	Form · route	Labeler	Product NDC
Infumorph 200morphine sulfate	Morphine sulfate 10 mg/mL	Injection, SolutionEpidural, Intrathecal	Hikma Pharmaceuticals USA Inc.	0641-6039
Duramorphmorphine sulfate	Morphine sulfate 1 mg/mL	InjectionEpidural, Intrathecal, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6019
Duramorphmorphine sulfate	Morphine sulfate .5 mg/mL	InjectionEpidural, Intrathecal, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6020