Prescription drug · ANDA
Morphine Sulfate NDC 0406-8003
Morphine sulfate 20 mg/mL · Solution · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8003-12 | 00406800312 | 6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2011 | |
| 0406-8003-15 | 00406800315 | 6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2011 | |
| 0406-8003-24 | 00406800324 | 6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2011 | |
| 0406-8003-30 | 00406800330 | 6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2011 |
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)
- Morphine Sulfate
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202348
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0406-8003_c946a19a-39f9-4c54-8715-0918f976b8bcSPL ID c946a19a-39f9-4c54-8715-0918f976b8bcSPL set ID 242c2512-1d49-486b-a9c3-6905f667799eRxCUI 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
N400406800312followed by a unit qualifier and the quantityPackage 00406-8003-12. 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 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate 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 and persist over the course of therapy [see Warnings and Precautions ( 5.2 )] , reserve opioid analgesics, including morphine sulfate oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient…
Excerpt only. Read the full label for complete information.