NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3851Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3851Add 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
70518-3851-27051838510230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3851-2)Marketed from Jun 6, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210425
Marketing start
Listing expires
Other FDA classes
Alkaloids (Chemical structure)
Identifiers
Product ID 70518-3851_54da0ff6-6f8e-b862-e063-6294a90a9b55SPL ID 54da0ff6-6f8e-b862-e063-6294a90a9b55SPL set ID f818ffe0-43df-4cc6-bc86-00b2c79b06fcRxCUI 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

N470518385102 followed by a unit qualifier and the quantity

Package 70518-3851-02. 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)

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
ProductStrengthForm · routeLabelerProduct NDC
ColchicineColchicine .6 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-002
ColchicineColchicine .6 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-494
ColchicineColchicine .6 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-082
ColchicineColchicine .6 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7120

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