Prescription drug · ANDA
Morphine Sulfate NDC 63629-2301
Morphine sulfate 20 mg/mL · Solution · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2301-1 | 63629230101 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (63629-2301-1) / 30 mL in 1 BOTTLE, UNIT-DOSEMarketed from Sep 21, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203518
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-2301_15cba551-b5db-420f-98c0-16c6bca528edSPL ID 15cba551-b5db-420f-98c0-16c6bca528edSPL set ID 9bb1fef7-4159-4dca-8a8c-37e53ccc6babRxCUI 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
N463629230101followed by a unit qualifier and the quantityPackage 63629-2301-01. 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. 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 patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203518
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/mL | SolutionOral | American Health Packaging | 68000-110 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | Bryant Ranch Prepack | 63629-2302 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-114 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-111 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-112 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-113 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | Cranbury Pharmaceuticals, LLC | 27808-082 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | Bryant Ranch Prepack | 72162-1282 |