Prescription drug · ANDA
Morphine Sulfate Extended Release NDC 42858-801
morphine sulfate · Morphine sulfate 15 mg/1 · Tablet, Film coated, Extended release · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-801-01 | 42858080101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-801-01)Marketed from Jan 14, 2011 |
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 Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 15 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074862
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-801_ccb2d4f4-3f19-40cd-9653-cec37213f8a0SPL ID ccb2d4f4-3f19-40cd-9653-cec37213f8a0SPL set ID 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804RxCUI 891874, 891881, 891888, 891893, 892646UNII X3P646A2J0UPC 0342858804011, 0342858803014, 0342858801010, 0342858802017, 0342858805018
- 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
N442858080101followed by a unit qualifier and the quantityPackage 42858-0801-01. 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 extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 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 analgesic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074862
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 Extended Releasemorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6559 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-157 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-158 |
| Morphine Sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-4484 |
| Morphine Sulfate ERmorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-4483 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-802 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-803 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6557 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6558 |