Prescription drug · ANDA
Morphine Sulfate NDC 75826-130
Morphine sulfate 20 mg/5mL · Solution · Oral · Winder Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75826-130-05 | 7582601300575826013005 | 100 mL in 1 BOTTLE, PLASTIC (75826-130-05)Marketed from May 15, 2019 | |
| 75826-130-17 | 7582601301775826013017 | 500 mL in 1 BOTTLE, PLASTIC (75826-130-17)Marketed from May 15, 2019 |
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 — 20 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Winder Laboratories LLCNDC labeler code 75826
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211454
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 75826-130_2b0eba4c-7f43-72ef-e063-6294a90afd7eSPL ID 2b0eba4c-7f43-72ef-e063-6294a90afd7eSPL set ID e9a7319a-bf1f-48db-a71e-6d4e6ead9555RxCUI 892589, 892625, 894780UNII X3P646A2J0UPC 0375826130058, 0375826131154, 0375826129052
- 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
N475826013005followed by a unit qualifier and the quantityPackage 75826-0130-05. 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 Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients . Morphine Sulfate Oral Solution is an opioid agonist. Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Morphine Sulfate Oral Solution 20 mg/mL is indicated for: the relief of acute and chr…
Excerpt only. Read the full label for complete information.
About NDC 75826-130
- What is NDC 75826-130?
- 75826-130 is the product NDC for Morphine Sulfate, Morphine sulfate 20 mg/5mL solution, listed with the FDA by Winder Laboratories LLC. It has 2 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?
- Winder Laboratories LLC, NDC labeler code 75826. 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 211454
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/5mL | SolutionOral | Winder Laboratories LLC | 75826-129 |
| Morphine Sulfate | Morphine sulfate 100 mg/5mL | SolutionOral | Winder Laboratories LLC | 75826-131 |