Prescription drug · NDA
Gloperba (colchicine) NDC 69557-222
Colchicine .6 mg/5mL · Solution · Oral · Scilex Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69557-222-01 | 69557022201 | 1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLEMarketed from Jan 31, 2024 |
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)
- Gloperba
- Generic name (nonproprietary)
- colchicine
- Active ingredients
- Colchicine — .6 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Scilex Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210942
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 69557-222_25e07ab6-c140-6aae-e063-6394a90ac06eSPL ID 25e07ab6-c140-6aae-e063-6394a90ac06eSPL set ID 467cd83f-d695-4040-9434-10e80b4271daRxCUI 2118892, 2180558UNII SML2Y3J35T
- Pharmacologic class
- Alkaloid
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
N469557022201followed by a unit qualifier and the quantityPackage 69557-0222-01. 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 .
Indications (excerpt from the label)
GLOPERBA ® (colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults. GLOPERBA is indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes ( 1 ). Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
Excerpt only. Read the full label for complete information.