Prescription drug · NDA
Duramorph (morphine sulfate) NDC 0641-6019
Morphine sulfate 1 mg/mL · Injection · Epidural, Intrathecal, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6019-10 | 00641601910 | 10 AMPULE in 1 CARTON (0641-6019-10) / 10 mL in 1 AMPULE (0641-6019-01)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)
- Duramorph
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 1 mg/mL
- Dosage form
- Injection
- Route
- Epidural, Intrathecal, Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018565
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-6019_aa74af85-7068-4254-9a79-c7f3792044a6SPL ID aa74af85-7068-4254-9a79-c7f3792044a6SPL set ID ebb18761-e5c4-4238-bb84-f9549f500210RxCUI 892473, 892489, 1728783, 1728800UNII 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641601910followed by a unit qualifier and the quantityPackage 00641-6019-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
DURAMORPH is indicated for: the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for which alternative treatments are not expected to be adequate. the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Limitation of Use DURAMORPH is not for use in continuous microinfusion devices. 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 (5.2) ] , reserve opioid analgesiscs, including DURAMORPH for use in patients for whom alternative treatment options are…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018565
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Infumorph 200morphine sulfate | Morphine sulfate 10 mg/mL | Injection, SolutionEpidural, Intrathecal | Hikma Pharmaceuticals USA Inc. | 0641-6039 |
| Infumorph 500morphine sulfate | Morphine sulfate 25 mg/mL | Injection, SolutionEpidural, Intrathecal | Hikma Pharmaceuticals USA Inc. | 0641-6040 |
| Duramorphmorphine sulfate | Morphine sulfate .5 mg/mL | InjectionEpidural, Intrathecal, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6020 |