Prescription drug · ANDA
colchicine NDC 67877-589
Colchicine .6 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-589-01 | 6787705890167877058901 | 100 TABLET in 1 BOTTLE (67877-589-01)Marketed from Feb 10, 2019 | |
| 67877-589-05 | 6787705890567877058905 | 500 TABLET in 1 BOTTLE (67877-589-05)Marketed from Feb 10, 2019 | |
| 67877-589-10 | 6787705891067877058910 | 1000 TABLET in 1 BOTTLE (67877-589-10)Marketed from Feb 10, 2019 | |
| 67877-589-30 | 6787705893067877058930 | 30 TABLET in 1 BOTTLE (67877-589-30)Marketed from Feb 10, 2019 | |
| 67877-589-33 | 6787705893367877058933 | 1 BLISTER PACK in 1 CARTON (67877-589-33) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 10, 2019 | |
| 67877-589-60 | 6787705896067877058960 | 60 TABLET in 1 BOTTLE (67877-589-60)Marketed from Feb 10, 2019 | |
| 67877-589-84 | 6787705898467877058984 | 3 BLISTER PACK in 1 CARTON (67877-589-84) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 10, 2019 | |
| 67877-589-86 | 6787705898667877058986 | 250 TABLET in 1 BOTTLE (67877-589-86)Marketed from Feb 10, 2019 |
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
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- 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 67877-589_e2293bee-2640-4247-9e1d-5f776c3be15eSPL ID e2293bee-2640-4247-9e1d-5f776c3be15eSPL set ID a4284783-fea6-4af2-9a8d-79c929176c05RxCUI 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
N467877058901followed by a unit qualifier and the quantityPackage 67877-0589-01. 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 67877-589
- What is NDC 67877-589?
- 67877-589 is the product NDC for colchicine, Colchicine .6 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 8 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 | 63629-8362 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8766 |
| colchicine | Colchicine .6 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2567 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1855 |