Prescription drug · NDA
Colchicine NDC 72189-249
Colchicine .6 mg/1 · Tablet, Film coated · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-249-03 | 72189024903 | 3 TABLET, FILM COATED in 1 BOTTLE (72189-249-03)Marketed from Jul 23, 2021 |
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
- Tablet, Film coated
- Route
- Oral
- Labeler
- direct rx
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022352
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 72189-249_2c28c181-51d4-7164-e063-6394a90a1d0cSPL ID 2c28c181-51d4-7164-e063-6394a90a1d0cSPL set ID c7d013b7-0a67-0953-e053-2a95a90ac47cRxCUI 197541UNII 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
N472189024903followed by a unit qualifier and the quantityPackage 72189-0249-03. 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)
1.1 Gout Flares Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares: Colchicine Tablets, USP are indicated for prophylaxis of gout flares. Treatment of Gout Flares: Colchicine Tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) Colchicine Tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022352
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 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2166 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2167 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1802 |
| Colcryscolchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-292 |