Prescription drug · ANDA
colchicine NDC 43598-372
Colchicine .6 mg/1 · Tablet · Oral · Dr.Reddys Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-372-01 | 4359803720143598037201 | 100 TABLET in 1 BOTTLE (43598-372-01)Marketed from Jun 11, 2020 | |
| 43598-372-10 | 4359803721043598037210 | 1000 TABLET in 1 BOTTLE (43598-372-10)Marketed from Sep 4, 2020 | |
| 43598-372-30 | 4359803723043598037230 | 30 TABLET in 1 BOTTLE (43598-372-30)Marketed from Jun 11, 2020 |
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
- Dr.Reddys Laboratories, Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209876
- Marketing start
- Listing expires
- Other FDA classes
- Alkaloids (Chemical structure)
- Identifiers
- Product ID 43598-372_1ec57a05-1536-7b6a-a90e-3dd40c9f72d2SPL ID 1ec57a05-1536-7b6a-a90e-3dd40c9f72d2SPL set ID 2cd5298e-43c6-a8dc-4467-9a3e1ade9307RxCUI 197541UNII SML2Y3J35TUPC 0343598372013, 0343598372105
- 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
N443598037201followed by a unit qualifier and the quantityPackage 43598-0372-01. 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.
About NDC 43598-372
- What is NDC 43598-372?
- 43598-372 is the product NDC for colchicine, Colchicine .6 mg/1 tablet, listed with the FDA by Dr.Reddys Laboratories, Inc.. It has 3 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?
- Dr.Reddys Laboratories, Inc., NDC labeler code 43598. 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 209876
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 | REMEDYREPACK INC. | 70518-4000 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Proficient Rx LP | 71205-687 |
| colchicine | Colchicine .6 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1738 |
| Colchicine | Colchicine .6 mg/1 | TabletOral | Direct Rx | 72189-331 |