Prescription drug · ANDA
Colchicine NDC 70710-1571
Colchiceine .3 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1571-1 | 70710157101 | 1 BOTTLE in 1 CARTON (70710-1571-1) / 100 TABLET in 1 BOTTLEMarketed from May 10, 2021 | |
| 70710-1571-3 | 70710157103 | 1 BOTTLE in 1 CARTON (70710-1571-3) / 30 TABLET in 1 BOTTLEMarketed from May 10, 2021 | |
| 70710-1571-5 | 70710157105 | 1 BOTTLE in 1 CARTON (70710-1571-5) / 500 TABLET in 1 BOTTLEMarketed from May 10, 2021 | |
| 70710-1571-9 | 70710157109 | 1 BOTTLE in 1 CARTON (70710-1571-9) / 90 TABLET in 1 BOTTLEMarketed from May 10, 2021 |
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
- Colchiceine — .3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211519
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1571_cf874687-3377-4fd3-9616-6c1f74454ad3SPL ID cf874687-3377-4fd3-9616-6c1f74454ad3SPL set ID c8fd7034-5ca2-4a58-b303-7f78ffdf8d76UNII 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
N470710157101followed by a unit qualifier and the quantityPackage 70710-1571-01. 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.
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 | Northstar Rx LLC. | 16714-039 |
| Colchicine | Colchiceine .3 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1590 |
| Colchicine | Colchiceine .6 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1351 |
| Colchicine | Colchiceine .6 mg/1 | TabletOral | A-S Medication Solutions | 50090-7205 |
| Colchicine | Colchiceine .6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1396 |