Prescription drug · ANDA
Colchicine NDC 31722-899
Colchicine .6 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-899-01 | 31722089901 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-899-01)Marketed from Aug 13, 2021 | |
| 31722-899-30 | 31722089930 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-899-30)Marketed from Aug 13, 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
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208993
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Interactions (Mechanism)
- Identifiers
- Product ID 31722-899_c9c0c7c1-6f07-596e-e053-2995a90aae1eSPL ID c9c0c7c1-6f07-596e-e053-2995a90aae1eSPL set ID 1e7ef16d-262b-4dc0-92d6-7afe4aa21ebdRxCUI 197541UNII SML2Y3J35TUPC 0331722899307
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
N431722089901followed by a unit qualifier and the quantityPackage 31722-0899-01. 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 tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults (1.1). • Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets 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 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 ANDA 208993
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 | Direct_Rx | 72189-687 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-572 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2791 |