Prescription drug · ANDA
Colchicine NDC 33342-341
Colchicine .6 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-341-07 | 3334203410733342034107 | 30 TABLET in 1 BOTTLE (33342-341-07)Marketed from Aug 23, 2018 | |
| 33342-341-11 | 3334203411133342034111 | 100 TABLET in 1 BOTTLE (33342-341-11)Marketed from Aug 23, 2018 | |
| 33342-341-15 | 3334203411533342034115 | 500 TABLET in 1 BOTTLE (33342-341-15)Marketed from Aug 23, 2018 | |
| 33342-341-42 | 3334203414233342034142 | 11 BLISTER PACK in 1 CARTON (33342-341-42) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 23, 2018 |
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
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210633
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 33342-341_9111bbad-b020-44fb-b276-d7853e5acd2cSPL ID 9111bbad-b020-44fb-b276-d7853e5acd2cSPL set ID 9111bbad-b020-44fb-b276-d7853e5acd2cRxCUI 197541UNII SML2Y3J35TUPC 0333342341112, 0333342341150
- 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
N433342034107followed by a unit qualifier and the quantityPackage 33342-0341-07. 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 tablet is an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults (1.1). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares : colchicine tablets is indicated for prophylaxis of gout flares. • Treatment of Gout Flares : colchicine tablets tablets 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 are indicated in adults and children four years or older for treatment of familial Mediterranean fever…
Excerpt only. Read the full label for complete information.
About NDC 33342-341
- What is NDC 33342-341?
- 33342-341 is the product NDC for Colchicine, Colchicine .6 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colchicine.
- What is the active ingredient?
- Colchicine.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colchicine?
- 48 other product NDCs are listed under this name. See all Colchicine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colchicine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-687 | 72189-0687-03 |
| colchicine | Colchicine .6 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-839 | 60760-0839-10 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Micro Labs Limited | 42571-341 | 42571-0341-0142571-0341-1042571-0341-30 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Coupler LLC | 67046-1634 | 67046-1634-03 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Coupler LLC | 67046-0889 | 67046-0889-03 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-099 | 31722-0099-0131722-0099-1031722-0099-30 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Granules Pharmaceutical Inc. | 70010-001 | 70010-0001-0170010-0001-0370010-0001-10 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2703 | 71335-2703-0171335-2703-0271335-2703-03+5 more |
| colchicine | Colchicine .6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4000 | 70518-4000-01 |
| Colchicine | Colchicine .6 mg/1 | CapsuleOral | Par Health USA, LLC | 0254-0460 | 00254-0460-01 |