Colchicine NDC 65162-710

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-710Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0710Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65162-710-03	65162071003	30 TABLET in 1 BOTTLE (65162-710-03)Marketed from Sep 30, 2016
65162-710-09	65162071009	90 TABLET in 1 BOTTLE (65162-710-09)Marketed from Sep 30, 2016
65162-710-11	65162071011	1000 TABLET in 1 BOTTLE (65162-710-11)Marketed from Sep 30, 2016

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
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204711
Marketing start: Sep 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Alkaloids (Chemical structure)
Identifiers: Product ID 65162-710_74974eef-499f-456f-8683-da23bb0c1137SPL ID 74974eef-499f-456f-8683-da23bb0c1137SPL set ID 7daef7e2-888d-4116-81a9-2c02b9ef97efRxCUI 197541UNII SML2Y3J35TUPC 0365162710113
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

N465162071003 followed by a unit qualifier and the quantity

Package 65162-0710-03. 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 Mar 27, 2025.

Indications (excerpt from the label)

Colchicine tablets, USP 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, 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 Mediterr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204711

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204711
Product	Strength	Form · route	Labeler	Product NDC
Colchicine	Colchicine .6 mg/1	TabletOral	AvPAK	50268-187