Prescription drug · NDA
MS Contin (Morphine sulfate) NDC 42858-631
Morphine sulfate 30 mg/1 · Tablet, Film coated, Extended release · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-631-01 | 4285806310142858063101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-631-01)Marketed from May 15, 2017 |
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)
- MS Contin
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 30 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLCNDC labeler code 42858
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019516
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-631_8a5edf84-32d5-44f2-afad-7589689f3175SPL ID 8a5edf84-32d5-44f2-afad-7589689f3175SPL set ID c354b3bf-86c0-4bb8-8b1f-be2164942698RxCUI 891881, 891888, 891893, 892574, 892660, 894813UNII X3P646A2J0UPC 0342858631013, 0342858515016, 0342858760010
- 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
N442858063101followed by a unit qualifier and the quantityPackage 42858-0631-01. 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)
MS CONTIN is 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. 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 MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. MS CONTIN is not indicated as an as-needed (prn) analgesic. MS CONTI…
Excerpt only. Read the full label for complete information.
About NDC 42858-631
- What is NDC 42858-631?
- 42858-631 is the product NDC for MS Contin (morphine sulfate), Morphine sulfate 30 mg/1 tablet, film coated, extended release, listed with the FDA by Rhodes Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- MS Contin (Morphine sulfate).
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Rhodes Pharmaceuticals LLC, NDC labeler code 42858. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for MS Contin?
- 2 other product NDCs are listed under this name. See all MS Contin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other MS Contin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| MS Continmorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-515 | 42858-0515-01 |
| MS Continmorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-760 | 42858-0760-01 |
Other NDCs under NDA 019516
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 |
|---|---|---|---|---|
| MS Continmorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-515 |
| MS Continmorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-760 |