Prescription drug · ANDA
Morphine sulfate NDC 0228-3117
Morphine sulfate 75 mg/1 · Capsule, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-3117-11 | 0022831171100228311711 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3117-11)Marketed from Feb 4, 2014 |
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 — 75 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079040
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0228-3117_e8d8d264-9e4b-4d7f-bbb3-0f2546562ad0SPL ID e8d8d264-9e4b-4d7f-bbb3-0f2546562ad0
- 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
N400228311711followed by a unit qualifier and the quantityPackage 00228-3117-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0228-3117
- What is NDC 0228-3117?
- 0228-3117 is the product NDC for Morphine sulfate, Morphine sulfate 75 mg/1 capsule, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Morphine sulfate.
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0228. 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?
- 126 other product NDCs are listed under this name. See all Morphine sulfate 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 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 | Morphine sulfate 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-893 | 60760-0893-60 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-110 | 68000-0110-01 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-111 | 68000-0111-05 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-112 | 68000-0112-05 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-113 | 68000-0113-03 |
| Morphine Sulfate | Morphine sulfate 20 mg/mL | SolutionOral | American Health Packaging | 68000-114 | 68000-0114-03 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | American Health Packaging | 60687-927 | 60687-0927-86 |
| Morphine Sulfate | Morphine sulfate 10 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4955 | 00121-4955-94 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-556 | 68094-0556-58 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-156 | 68094-0156-58 |
Other NDCs under ANDA 079040
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 30 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3090 |
| Morphine sulfate | Morphine sulfate 60 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3091 |
| Morphine sulfate | Morphine sulfate 90 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3092 |
| Morphine sulfate | Morphine sulfate 120 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3093 |
| Morphine sulfate | Morphine sulfate 45 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-3116 |