Prescription drug · ANDA
Morphine Sulfate NDC 63629-4484
Morphine sulfate 30 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4484-0 | 6362944840063629448400 | 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-0)Marketed from Dec 22, 2021 | |
| 63629-4484-1 | 6362944840163629448401 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-1)Marketed from Apr 18, 2011 | |
| 63629-4484-2 | 6362944840263629448402 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-2)Marketed from Apr 18, 2011 | |
| 63629-4484-3 | 6362944840363629448403 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-3)Marketed from May 3, 2011 | |
| 63629-4484-4 | 6362944840463629448404 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-4)Marketed from May 7, 2012 | |
| 63629-4484-5 | 6362944840563629448405 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-5)Marketed from Aug 25, 2011 | |
| 63629-4484-6 | 6362944840663629448406 | 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-6)Marketed from Dec 22, 2021 | |
| 63629-4484-7 | 6362944840763629448407 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-7)Marketed from Apr 29, 2014 | |
| 63629-4484-8 | 6362944840863629448408 | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-8)Marketed from Dec 22, 2021 | |
| 63629-4484-9 | 6362944840963629448409 | 26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-9)Marketed from Dec 22, 2021 |
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 — 30 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-4484_f76e4a94-1e80-4147-a689-c5b13661c7daSPL ID f76e4a94-1e80-4147-a689-c5b13661c7daSPL set ID cc3b491c-a206-3027-54f0-f87c0dd40a7fRxCUI 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
N463629448400followed by a unit qualifier and the quantityPackage 63629-4484-00. 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 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. Morphine sulfate extended-release tablets are an opioid agonist 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. ( 1 ) 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, reserve morphine sulfate …
Excerpt only. Read the full label for complete information.
About NDC 63629-4484
- What is NDC 63629-4484?
- 63629-4484 is the product NDC for Morphine Sulfate, Morphine sulfate 30 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 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 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 | Major Pharmaceuticals | 0904-6557 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6558 |
| 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 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 | American Health Packaging | 68084-157 |
| Morphine Sulfate Extended Releasemorphine sulfate | Morphine sulfate 30 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-158 |