Prescription drug · ANDA
Morphine Sulfate NDC 60687-617
Morphine sulfate 15 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-617-01 | 60687061701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-617-01) / 1 TABLET in 1 BLISTER PACK (60687-617-11)Marketed from Oct 18, 2021 |
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
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212451
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60687-617_45364b66-8b1b-f778-e063-6394a90aa2e1SPL ID 45364b66-8b1b-f778-e063-6394a90aa2e1SPL set ID d66d0cfb-9bfe-490c-90ee-49481c567e85RxCUI 892582UNII 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
N460687061701followed by a unit qualifier and the quantityPackage 60687-0617-01. 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 tablets are indicated for the management of: adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions (5.1) ] , reserve morphine sulfate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212451
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 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8459 |
| Morphine Sulfate | Morphine sulfate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9662 |
| Morphine Sulfate | Morphine sulfate 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-893 |
| Morphine Sulfate | Morphine sulfate 15 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-670 |
| Morphine Sulfate | Morphine sulfate 30 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-671 |