Prescription drug · NDA
Morphine Sulfate NDC 76045-007
Morphine sulfate 8 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi, USA LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Morphine Sulfate
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 8 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi, USA LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204223
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 76045-007_e61f6eb4-cc71-47d3-b2f6-5e689c773779SPL ID e61f6eb4-cc71-47d3-b2f6-5e689c773779SPL set ID 1f53de80-efc8-4930-b3e3-fba0d026af05RxCUI 894912, 894914, 998212, 998213, 1442790, 2752697UNII 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) Morphine Sulfate Injection is indicated for the management of pain severe enough to require …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204223
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 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-006 |
| Morphine Sulfate | Morphine sulfate 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-004 |
| Morphine Sulfate | Morphine sulfate 4 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-005 |
| Morphine Sulfate | Morphine sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-008 |
| Morphine Sulfate | Morphine sulfate 1 mg/.5mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-238 |
| Morphine Sulfate | Morphine sulfate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-451 |
| Morphine Sulfate | Morphine sulfate 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-452 |
| Morphine Sulfate | Morphine sulfate 4 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-454 |
| Morphine Sulfate | Morphine sulfate 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-455 |
| Morphine Sulfate | Morphine sulfate 8 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-458 |