Prescription drug · ANDA
Colchicine NDC 59651-446
Colchicine .6 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-446-01 | 59651044601 | 100 CAPSULE in 1 BOTTLE (59651-446-01)Marketed from Apr 29, 2024 | |
| 59651-446-30 | 59651044630 | 30 CAPSULE in 1 BOTTLE (59651-446-30)Marketed from Jul 1, 2024 | |
| 59651-446-99 | 59651044699 | 1000 CAPSULE in 1 BOTTLE (59651-446-99)Marketed from Apr 29, 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)
- Colchicine
- Generic name (nonproprietary)
- colchicine
- Active ingredients
- Colchicine — .6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215463
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 59651-446_4ccdf563-ca5a-439d-acdd-35067133be31SPL ID 4ccdf563-ca5a-439d-acdd-35067133be31SPL set ID a1ff526f-e89f-4dca-80b6-653d6bdfd895RxCUI 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
N459651044601followed by a unit qualifier and the quantityPackage 59651-0446-01. 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 ANDA 215463
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 | Bryant Ranch Prepack | 71335-2703 |