Colchicine NDC 71610-494

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-494Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0494Add 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	Copy
71610-494-03	71610049403	9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03)Marketed from Nov 17, 2020

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210425
Marketing start: Feb 5, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Interactions (Mechanism)
Identifiers: Product ID 71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235SPL ID 543ae21a-60f3-49e2-8bad-b9ee0f412235SPL set ID b310c57c-9192-4dc8-b76f-2c1982941cafRxCUI 197541UNII SML2Y3J35T

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

N471610049403 followed by a unit qualifier and the quantity

Package 71610-0494-03. 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 Dec 16, 2020.

Indications (excerpt from the label)

Colchicine is an alkaloid indicated for: • Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210425

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

FDA NDC Directory listings under ANDA 210425
Product	Strength	Form · route	Labeler	Product NDC
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Granules Pharmaceuticals Inc.	70010-002
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-082
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7120
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3851