Prescription drug · NDA
Morphine Sulfate NDC 68094-356
Morphine sulfate 100 mg/5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-356-58 | 6809403565868094035658 | 50 BAG in 1 CASE (68094-356-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-356-01)Marketed from Nov 30, 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 — 100 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022195
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68094-356_8e3a610d-ef85-459c-96f9-bde97983a25aSPL ID 8e3a610d-ef85-459c-96f9-bde97983a25aSPL set ID 6654b91e-3b3f-4062-ac65-a2a70f942da4RxCUI 892625UNII 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
N468094035658followed by a unit qualifier and the quantityPackage 68094-0356-58. 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 and 4 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, which can occur at any dosage or duration [see Warnings and Precautions (5.2) ] , reserve Morphine Sulfate…
Excerpt only. Read the full label for complete information.
About NDC 68094-356
- What is NDC 68094-356?
- 68094-356 is the product NDC for Morphine Sulfate, Morphine sulfate 100 mg/5mL solution, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Morphine Sulfate.
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Precision Dose, Inc., NDC labeler code 68094. 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 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 10 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0237 |
| Morphine Sulfate | Morphine sulfate 20 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0238 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0517 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0904 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | American Health Packaging | 60687-760 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | Precision Dose Inc. | 68094-001 |
| 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. | 68094-556 |