Prescription drug · NDA
Colcrys (Colchicine) NDC 63187-292
Colchicine .6 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-292-03 | 63187029203 | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-292-03)Marketed from Jan 1, 2019 |
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)
- Colcrys
- Generic name (nonproprietary)
- colchicine
- Active ingredients
- Colchicine — .6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022352
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Interactions (Mechanism)
- Identifiers
- Product ID 63187-292_db4b884e-dd04-4097-83fe-a42f171bf9a5SPL ID db4b884e-dd04-4097-83fe-a42f171bf9a5SPL set ID d6adc880-5499-4691-93f3-27c87902d5fcRxCUI 197541, 858071UNII SML2Y3J35TUPC 0363187292034
- 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
N463187029203followed by a unit qualifier and the quantityPackage 63187-0292-03. 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)
COLCRYS (colchicine, USP) 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 ). COLCRYS is not an analgesic medication and should not be used to treat pain from other causes. 1.1 Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: COLCRYS is indicated for prophylaxis of gout flares. • Treatment of Gout Flares: COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) COLCRYS (colchic…
Excerpt only. Read the full label for complete information.
About NDC 63187-292
- What is NDC 63187-292?
- 63187-292 is the product NDC for Colcrys (colchicine), Colchicine .6 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colcrys (Colchicine).
- What is the active ingredient?
- Colchicine.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colcrys?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | direct rx | 72189-249 |