Prescription drug · NDA
Lodoco (Colchicine tablets 0.5 mg) NDC 82867-001
Colchicine .5 mg/1 · Tablet · Oral · AGEPHA Pharma USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82867-001-01 | 82867000101 | 1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2023 | |
| 82867-001-02 | 82867000102 | 1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2023 · Sample package |
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)
- Lodoco
- Generic name (nonproprietary)
- colchicine tablets 0.5 mg
- Active ingredients
- Colchicine — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AGEPHA Pharma USA, LLCNDC labeler code 82867
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215727
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 82867-001_58b0922c-5767-1f3f-e063-6394a90a88ccSPL ID 58b0922c-5767-1f3f-e063-6394a90a88ccSPL set ID ff06d68f-d65f-d097-e053-6294a90a7e5fRxCUI 197540, 2663988UNII SML2Y3J35TUPC 0382867001018, 0382867001025
- 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
N482867000101followed by a unit qualifier and the quantityPackage 82867-0001-01. 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)
1. INDICATION AND USAGE LODOCO is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. LODOCO is an alkaloid indicated: • to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 82867-001
- What is NDC 82867-001?
- 82867-001 is the product NDC for Lodoco (colchicine tablets 0.5 mg), Colchicine .5 mg/1 tablet, listed with the FDA by AGEPHA Pharma USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lodoco (Colchicine Tablets 0.5 mg).
- What is the active ingredient?
- Colchicine.
- Who is the labeler?
- AGEPHA Pharma USA, LLC, NDC labeler code 82867. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lodoco?
- 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.