Prescription drug · ANDA
Colchicine NDC 16714-039
Colchiceine .6 mg/1 · Tablet · Oral · Northstar Rx LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-039-01 | 1671400390116714003901 | 1 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLEMarketed from Nov 10, 2020 | |
| 16714-039-02 | 1671400390216714003902 | 1 BOTTLE in 1 CARTON (16714-039-02) / 100 TABLET in 1 BOTTLEMarketed from Nov 10, 2020 |
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
- Colchiceine — .6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northstar Rx LLC.NDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211519
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45SPL ID b510d002-4c8e-4b5e-bc76-c49552e79d45SPL set ID 94bee24f-d846-4344-bc42-b2eae6b433baUNII HJ30158L57
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
N416714003901followed by a unit qualifier and the quantityPackage 16714-0039-01. 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)
Colchicine tablets are 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 are indicated for prophylaxis of gout flares. Treatment of Gout Flares: Colchicine 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 (FMF).…
Excerpt only. Read the full label for complete information.
About NDC 16714-039
- What is NDC 16714-039?
- 16714-039 is the product NDC for Colchicine, Colchiceine .6 mg/1 tablet, listed with the FDA by Northstar Rx LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colchicine.
- What is the active ingredient?
- Colchiceine.
- Who is the labeler?
- Northstar Rx LLC., NDC labeler code 16714. 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 |
Other NDCs under ANDA 211519
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Colchicine | Colchiceine .6 mg/1 | TabletOral | A-S Medication Solutions | 50090-7205 |
| Colchicine | Colchiceine .6 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1351 |
| Colchicine | Colchiceine .3 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1571 |
| Colchicine | Colchiceine .6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1396 |
| Colchicine | Colchiceine .3 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1590 |