Prescription drug · ANDA
Colchicine NDC 70518-3851
Colchicine .6 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3851-2 | 70518385102 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3851-2)Marketed from Jun 6, 2024 |
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
- Colchicine — .6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210425
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 70518-3851_54da0ff6-6f8e-b862-e063-6294a90a9b55SPL ID 54da0ff6-6f8e-b862-e063-6294a90a9b55SPL set ID f818ffe0-43df-4cc6-bc86-00b2c79b06fcRxCUI 197541UNII 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
N470518385102followed by a unit qualifier and the quantityPackage 70518-3851-02. 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 is an alkaloid indicated for: • Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). 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 210425
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 | Colchicine .6 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-002 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-494 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-082 |
| Colchicine | Colchicine .6 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7120 |