Prescription drug · ANDA
Morphine Sulfate NDC 0832-0233
Morphine sulfate 100 mg/1 · Capsule, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0233-00 | 00832023300 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0233-00)Marketed from Jun 30, 2013 | |
| 0832-0233-50 | 00832023350 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0233-50)Marketed from Jun 30, 2013 |
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
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202104
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0832-0233_3984af25-b79e-1fe0-e063-6394a90ac936SPL ID 3984af25-b79e-1fe0-e063-6394a90ac936SPL set ID 97948a8f-7d1b-4614-b11d-e944cf56590bRxCUI 892345, 892352, 892494, 892554, 892596, 894801, 894814UNII X3P646A2J0UPC 0308320230009, 0308320228006, 0308320225005
- 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
N400832023300followed by a unit qualifier and the quantityPackage 00832-0233-00. 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 capsules 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. Morphine sulfate extended-release capsules is indicated for the management of severe and persistent pain that requires an extended period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) 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 f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202104
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 10 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0225 |
| Morphine Sulfate | Morphine sulfate 20 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0226 |
| Morphine Sulfate | Morphine sulfate 30 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0227 |
| Morphine Sulfate | Morphine sulfate 50 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0228 |
| Morphine Sulfate | Morphine sulfate 60 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0229 |
| Morphine Sulfate | Morphine sulfate 80 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-0230 |