NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3465Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3465Add 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
50090-3465-0500903465004 CAPSULE in 1 BOTTLE (50090-3465-0)Marketed from May 30, 2018
50090-3465-15009034650190 CAPSULE in 1 BOTTLE (50090-3465-1)Marketed from Jun 12, 2018

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
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 204820
Marketing start
Listing expires
Other FDA classes
Alkaloids (Chemical structure)
Identifiers
Product ID 50090-3465_0a10fc69-7083-42e4-9b2f-edbd0099017eSPL ID 0a10fc69-7083-42e4-9b2f-edbd0099017eSPL set ID 25307250-c16b-4467-9ad0-e6c752c576bdRxCUI 1550940UNII 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

N450090346500 followed by a unit qualifier and the quantity

Package 50090-3465-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 204820

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

FDA NDC Directory listings under NDA 204820
ProductStrengthForm · routeLabelerProduct NDC
ColchicineColchicine .6 mg/1CapsuleOralHikma Pharmaceuticals USA Inc.0143-3018
ColchicineColchicine .6 mg/1CapsuleOralMajor Pharmaceuticals0904-6732
MitigarecolchicineColchicine .6 mg/1CapsuleOralHikma Specialty USA Inc.59467-318
ColchicineColchicine .6 mg/1CapsuleOralCoupler LLC67046-0889
ColchicineColchicine .6 mg/1CapsuleOralAmerican Health Packaging60687-358

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