Prescription drug · ANDA
Colchicine NDC 70010-001
Colchicine .6 mg/1 · Capsule · Oral · Granules Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-001-01 | 70010000101 | 100 CAPSULE in 1 BOTTLE (70010-001-01)Marketed from Apr 29, 2024 | |
| 70010-001-03 | 70010000103 | 30 CAPSULE in 1 BOTTLE (70010-001-03)Marketed from Aug 22, 2024 | |
| 70010-001-10 | 70010000110 | 1000 CAPSULE in 1 BOTTLE (70010-001-10)Marketed from Apr 29, 2024 |
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
- Capsule
- Route
- Oral
- Labeler
- Granules Pharmaceutical Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210757
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 70010-001_3836b9fe-5628-fe23-e063-6294a90aa475SPL ID 3836b9fe-5628-fe23-e063-6294a90aa475SPL set ID 16d49c45-5b0a-a7fa-e063-6294a90a7320RxCUI 1550940UNII SML2Y3J35TUPC 0370010001039
- 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
N470010000101followed by a unit qualifier and the quantityPackage 70010-0001-01. 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)
Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. Colchicine capsule is an alkaloid indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of Use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.…
Excerpt only. Read the full label for complete information.