Prescription drug · ANDA
Colchicine NDC 0254-0460
Colchicine .6 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0254-0460-01 | 00254046001 | 100 CAPSULE in 1 BOTTLE (0254-0460-01)Marketed from Nov 1, 2023 |
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
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208678
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 0254-0460_3921574e-5169-46b3-9236-d23609465864SPL ID 3921574e-5169-46b3-9236-d23609465864SPL set ID eb509994-6ecc-4599-b87a-98495fef6129RxCUI 1550940UNII SML2Y3J35TUPC 0302540460017
- 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
N400254046001followed by a unit qualifier and the quantityPackage 00254-0460-01. 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 for acute treatment of gout flares during prophylaxis has not been studied. Colchicine is not an analgesic medication and should not be used to treat pain from other causes. Colchicine Capsule is an alkaloid indicated for prophylaxis of gout flares in adults (1). Limitations of use: The safety and effectiveness of colchicine for acute treatment of gout flares during prophylaxis has not been studied. Colchicine 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.