Prescription drug · ANDA
Morphine Sulfate Extended Release NDC 68084-157
morphine sulfate · Morphine sulfate 15 mg/1 · Tablet, Film coated, Extended release · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-157-01 | 68084015701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-157-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-157-11)Marketed from Nov 5, 2013 |
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
- American Health Packaging
- 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 68084-157_2a816b7d-8695-f031-e063-6294a90a3654SPL ID 2a816b7d-8695-f031-e063-6294a90a3654SPL set ID f915420d-981d-455b-b4cf-67c8e201a136RxCUI 891881, 891888UNII 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
N468084015701followed by a unit qualifier and the quantityPackage 68084-0157-01. 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 extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1) ], reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, …
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 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 15 mg/1 | Tablet, Film coated, Extended releaseOral | Rhodes Pharmaceuticals LLC | 42858-801 |
| 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 |