Prescription drug · ANDA
Morphine Sulfate Extended Release (Morphine sulfate) NDC 0904-6560
Morphine sulfate 100 mg/1 · Tablet, Film coated, Extended release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6560-61 | 0090465606100904656061 | 100 BLISTER PACK in 1 CARTON (0904-6560-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 14, 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 Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 100 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074769
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0904-6560_0253dd8d-875a-4483-887e-8819f8533b38SPL ID 0253dd8d-875a-4483-887e-8819f8533b38SPL set ID dbb37dfd-0196-45f7-b9ca-393f56cf1d28RxCUI 891874, 891881, 891888, 891893UNII 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
N400904656061followed by a unit qualifier and the quantityPackage 00904-6560-61. 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 analges…
Excerpt only. Read the full label for complete information.
About NDC 0904-6560
- What is NDC 0904-6560?
- 0904-6560 is the product NDC for Morphine Sulfate Extended Release, Morphine sulfate 100 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Morphine Sulfate Extended Release (Morphine Sulfate).
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 Extended Release?
- 12 other product NDCs are listed under this name. See all Morphine Sulfate Extended Release 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 Extended Release 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 Extended Releasemorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-157 | 68084-0157-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-158 | 68084-0158-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6557 | 00904-6557-61 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6558 | 00904-6558-61 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6559 | 00904-6559-61 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-801 | 42858-0801-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-802 | 42858-0802-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-803 | 42858-0803-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-804 | 42858-0804-01 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-805 | 42858-0805-01 |
Other NDCs under ANDA 074769
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 100 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-804 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-805 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-8505 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1352 |