Prescription drug · NDA
Mitigare (colchicine) NDC 59467-318
Colchicine .6 mg/1 · Capsule · Oral · Hikma Specialty USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59467-318-01 | 59467031801 | 100 CAPSULE in 1 BOTTLE (59467-318-01)Marketed from Oct 1, 2014 | |
| 59467-318-10 | 59467031810 | 1000 CAPSULE in 1 BOTTLE (59467-318-10)Marketed from Oct 1, 2014 | |
| 59467-318-30 | 59467031830 | 30 CAPSULE in 1 BOTTLE (59467-318-30)Marketed from Jul 26, 2018 |
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)
- Mitigare
- Generic name (nonproprietary)
- colchicine
- Active ingredients
- Colchicine — .6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Hikma Specialty USA Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204820
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152SPL ID 14dc4aa3-a989-41f6-9dd4-86f5490dc152SPL set ID cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2RxCUI 1550940, 1550946UNII 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
N459467031801followed by a unit qualifier and the quantityPackage 59467-0318-01. 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)
MITIGARE (colchicine) capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use: The safety and effectiveness of MITIGARE for acute treatment of gout flares during prophylaxis has not been studied. MITIGARE is not an analgesic medication and should not be used to treat pain from other causes. • MITIGARE is an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of Use : • The safety and effectiveness of MITIGARE for acute treatment of gout flares during prophylaxis has not been studied. • MITIGARE 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.
Other NDCs under NDA 204820
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 |
|---|---|---|---|---|
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0143-3018 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6732 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3465 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Coupler LLC | 67046-0889 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | American Health Packaging | 60687-358 |