Prescription drug · NDA
Morphine Sulfate NDC 63323-458
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, LLCNDC labeler code 63323
- 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 63323-458_f5584ff8-f338-4d14-b29e-e37b3978b747SPL ID f5584ff8-f338-4d14-b29e-e37b3978b747SPL set ID 582f42e5-444e-4246-af8c-e7e28097c69aRxCUI 1731993, 1732006, 1732011, 1732136, 2003714UNII X3P646A2J0UPC 0363323454005, 0363323451004
- 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 indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )], 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. Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe …
Excerpt only. Read the full label for complete information.
About NDC 63323-458
- What is NDC 63323-458?
- 63323-458 is the product NDC for Morphine Sulfate, Morphine sulfate 8 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC.
- What drug is associated with this NDC?
- Morphine Sulfate.
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Morphine Sulfate?
- 126 other product NDCs are listed under this name. See all Morphine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Morphine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Morphine Sulfate | Morphine sulfate 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-893 | 60760-0893-60 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-110 | 68000-0110-01 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-111 | 68000-0111-05 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-112 | 68000-0112-05 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-113 | 68000-0113-03 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-114 | 68000-0114-03 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | American Health Packaging | 60687-927 | 60687-0927-86 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4955 | 00121-4955-94 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-556 | 68094-0556-58 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-156 | 68094-0156-58 |
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 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 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 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-006 |
| Morphine Sulfate | Morphine sulfate 8 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi, USA LLC | 76045-007 |
| 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 |