NDC codes

FDA NDC Directory
Product NDC (as listed)69557-222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69557-0222Add 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
69557-222-0169557022201695570222011 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLEMarketed from Jan 31, 2024

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)
Gloperba
Generic name (nonproprietary)
colchicine
Active ingredients
Colchicine — .6 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Scilex Pharmaceuticals Inc.NDC labeler code 69557
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210942
Marketing start
Listing expires
Other FDA classes
Alkaloids (Chemical structure)
Identifiers
Product ID 69557-222_25e07ab6-c140-6aae-e063-6394a90ac06eSPL ID 25e07ab6-c140-6aae-e063-6394a90ac06eSPL set ID 467cd83f-d695-4040-9434-10e80b4271daRxCUI 2118892, 2180558UNII 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

N469557022201 followed by a unit qualifier and the quantity

Package 69557-0222-01. 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)

GLOPERBA ® (colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults. GLOPERBA is indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes ( 1 ). Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69557-222

What is NDC 69557-222?
69557-222 is the product NDC for Gloperba (colchicine), Colchicine .6 mg/5mL solution, listed with the FDA by Scilex Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gloperba (Colchicine).
What is the active ingredient?
Colchicine.
Who is the labeler?
Scilex Pharmaceuticals Inc., NDC labeler code 69557. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gloperba?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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