Prescription drug · NDA
Colchicine NDC 0143-3018
Colchicine .6 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-3018-01 | 00143301801 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)Marketed from Oct 1, 2014 | |
| 0143-3018-10 | 00143301810 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)Marketed from Oct 1, 2014 | |
| 0143-3018-30 | 00143301830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-30)Marketed from Jul 23, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Colchicine
- Generic name (nonproprietary)
- colchicine
- Active ingredients
- Colchicine — .6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- 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 0143-3018_76a875b0-99ff-4f9a-9113-ad5e122b7a79SPL ID 76a875b0-99ff-4f9a-9113-ad5e122b7a79SPL set ID ee1583ac-c308-4beb-b602-9ecac4977026RxCUI 1550940UNII 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
N400143301801followed by a unit qualifier and the quantityPackage 00143-3018-01. 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)
Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use : The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. Colchicine capsules are an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of Use : • The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. • Colchicine capsules are 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 | Major Pharmaceuticals | 0904-6732 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3465 |
| Mitigarecolchicine | Colchicine .6 mg/1 | CapsuleOral | Hikma Specialty USA Inc. | 59467-318 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Coupler LLC | 67046-0889 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | American Health Packaging | 60687-358 |