Prescription drug · ANDA
Morphine sulfate NDC 63629-1087
Morphine sulfate 15 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1087-1 | 63629108701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1087-1)Marketed from May 11, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078761
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-1087_5147c1c6-5b73-4301-8aab-4b3dc59b8c74SPL ID 5147c1c6-5b73-4301-8aab-4b3dc59b8c74SPL set ID 2f15f27b-95ed-4cc8-8937-eae07917a6ddRxCUI 891881UNII 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
N463629108701followed by a unit qualifier and the quantityPackage 63629-1087-01. 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 pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release 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, not tolerated, or would be otherwise inadequat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078761
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 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1790 |
| Morphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-1088 |
| Morphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-1089 |
| Morphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 63629-1091 |
| Morphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1789 |
| Morphine sulfate | Morphine sulfate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1791 |
| Morphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1792 |
| Morphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-1793 |
| Morphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-450 |
| Morphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-451 |
| Morphine sulfate | Morphine sulfate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-452 |
| Morphine sulfate | Morphine sulfate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-453 |
| Morphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-758 |
| Morphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0676 |
| Morphine sulfate | Morphine sulfate 60 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0707 |
| Morphine sulfate | Morphine sulfate 15 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0736 |
| Morphine sulfate | Morphine sulfate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-3080 |