Prescription drug · ANDA
colchicine NDC 63629-8362
Colchicine .6 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8362-1 | 6362983620163629836201 | 30 TABLET in 1 BOTTLE (63629-8362-1)Marketed from Nov 16, 2020 | |
| 63629-8362-2 | 6362983620263629836202 | 20 TABLET in 1 BOTTLE (63629-8362-2)Marketed from Sep 1, 2022 | |
| 63629-8362-3 | 6362983620363629836203 | 3 TABLET in 1 BOTTLE (63629-8362-3)Marketed from Sep 1, 2022 | |
| 63629-8362-4 | 6362983620463629836204 | 12 TABLET in 1 BOTTLE (63629-8362-4)Marketed from Sep 1, 2022 | |
| 63629-8362-5 | 6362983620563629836205 | 6 TABLET in 1 BOTTLE (63629-8362-5)Marketed from Sep 1, 2022 | |
| 63629-8362-6 | 6362983620663629836206 | 9 TABLET in 1 BOTTLE (63629-8362-6)Marketed from Sep 1, 2022 | |
| 63629-8362-7 | 6362983620763629836207 | 15 TABLET in 1 BOTTLE (63629-8362-7)Marketed from Sep 1, 2022 | |
| 63629-8362-8 | 6362983620863629836208 | 10 TABLET in 1 BOTTLE (63629-8362-8)Marketed from Sep 1, 2022 | |
| 63629-8362-9 | 6362983620963629836209 | 90 TABLET in 1 BOTTLE (63629-8362-9)Marketed from Sep 1, 2022 |
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
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211250
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 63629-8362_feb9803a-0e9b-4d56-ad3e-9bf9434605bbSPL ID feb9803a-0e9b-4d56-ad3e-9bf9434605bbSPL set ID 5ae87893-a065-468e-b8da-f1db86afcaefRxCUI 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
N463629836201followed by a unit qualifier and the quantityPackage 63629-8362-01. 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: · 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.
About NDC 63629-8362
- What is NDC 63629-8362?
- 63629-8362 is the product NDC for colchicine, Colchicine .6 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 211250
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 | TabletOral | A-S Medication Solutions | 50090-8014 |
| colchicine | Colchicine .6 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-839 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8766 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-589 |
| colchicine | Colchicine .6 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2567 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1855 |