NDC codes

FDA NDC Directory
Product NDC (as listed)72189-249Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0249Add 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 NDC11-digit (billing)PackageCopy
72189-249-03721890249033 TABLET, FILM COATED in 1 BOTTLE (72189-249-03)Marketed from Jul 23, 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
direct rx
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022352
Marketing start
Listing expires
Other FDA classes
Alkaloids (Chemical structure)
Identifiers
Product ID 72189-249_2c28c181-51d4-7164-e063-6394a90a1d0cSPL ID 2c28c181-51d4-7164-e063-6394a90a1d0cSPL set ID c7d013b7-0a67-0953-e053-2a95a90ac47cRxCUI 197541UNII SML2Y3J35T
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

N472189024903 followed by a unit qualifier and the quantity

Package 72189-0249-03. 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)

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 Mediterranean fever (FMF).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022352

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

FDA NDC Directory listings under NDA 022352
ProductStrengthForm · routeLabelerProduct NDC
ColchicineColchicine .6 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2166
ColchicineColchicine .6 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2167
ColchicineColchicine .6 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1802
ColcryscolchicineColchicine .6 mg/1Tablet, Film coatedOralProficient Rx LP63187-292

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