What is NDC 71610-494?

71610-494 is the product NDC for Colchicine, Colchicine .6 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Colchicine?

48 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Colchicine NDC 71610-494 | National Drug Code

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	7161004940371610049403	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, LLCNDC labeler code 71610
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)

About NDC 71610-494

What is NDC 71610-494?: 71610-494 is the product NDC for Colchicine, Colchicine .6 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Colchicine.
What is the active ingredient?: Colchicine.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Colchicine?: 48 other product NDCs are listed under this name. See all Colchicine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Colchicine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-687	72189-0687-03
colchicine	Colchicine .6 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-839	60760-0839-10
Colchicine	Colchicine .6 mg/1	CapsuleOral	Micro Labs Limited	42571-341	42571-0341-0142571-0341-1042571-0341-30
Colchicine	Colchicine .6 mg/1	CapsuleOral	Coupler LLC	67046-1634	67046-1634-03
Colchicine	Colchicine .6 mg/1	CapsuleOral	Coupler LLC	67046-0889	67046-0889-03
Colchicine	Colchicine .6 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-099	31722-0099-0131722-0099-1031722-0099-30
Colchicine	Colchicine .6 mg/1	CapsuleOral	Granules Pharmaceutical Inc.	70010-001	70010-0001-0170010-0001-0370010-0001-10
Colchicine	Colchicine .6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2703	71335-2703-0171335-2703-0271335-2703-03+5 more
colchicine	Colchicine .6 mg/1	TabletOral	REMEDYREPACK INC.	70518-4000	70518-4000-01
Colchicine	Colchicine .6 mg/1	CapsuleOral	Par Health USA, LLC	0254-0460	00254-0460-01

All 49 Colchicine NDCs

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	Major Pharmaceuticals	0904-7120
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-082
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Granules Pharmaceuticals Inc.	70010-002
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3851