Prescription drug · NDA
Morphine Sulfate NDC 60687-760
Morphine sulfate 10 mg/5mL · Solution · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-760-86 | 60687076086 | 3 TRAY in 1 CASE (60687-760-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-760-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-760-40)Marketed from Aug 1, 2023 |
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 — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022195
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60687-760_4353d803-4236-b8e9-e063-6394a90a6c62SPL ID 4353d803-4236-b8e9-e063-6394a90a6c62SPL set ID 9f1ba2a2-d8ac-4f59-a587-fe413e56dcdbRxCUI 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
N460687076086followed by a unit qualifier and the quantityPackage 60687-0760-86. 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)
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients . Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2) ], reserve Morphine Sulfate Oral Solution for use in pa…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022195
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 |
|---|---|---|---|---|
| Morphine Sulfate | Morphine sulfate 20 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0238 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0904 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0517 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | Precision Dose Inc. | 68094-001 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0237 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-045 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-056 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-156 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-356 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-556 |