colchicine .6 mg/1
colchicine · TABLET · Bryant Ranch Prepack
Colchicine is a prescription tablet taken by mouth used to treat gout attacks and prevent gout flares, as well as other inflammatory conditions. This medication works by reducing inflammation in the body and belongs to a class of drugs derived from natural plant sources.
Key Facts
- Brand Name
- colchicine
- Generic Name
- colchicine
- NDC Code (Product)
63629-8362- Manufacturer
- Bryant Ranch Prepack
- Strength
- .6 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211250
- Drug Class
- Alkaloid [EPC]
- Marketing Start
- 02/10/2019
Recall History
Health Innovations Pharmacy, Inc
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Granules Pharmaceuticals Inc.
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Aidapak Services, LLC
Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is colchicine used for?
Colchicine is a prescription tablet taken by mouth used to treat gout attacks and prevent gout flares, as well as other inflammatory conditions. This medication works by reducing inflammation in the body and belongs to a class of drugs derived from natural plant sources.
Is colchicine a controlled substance?
colchicine is not classified as a controlled substance by the DEA.
What is the generic name for colchicine?
The generic name for colchicine is colchicine. There are 8 other brand versions of colchicine.
What is the NDC code for colchicine .6 mg/1?
The NDC (National Drug Code) for colchicine .6 mg/1 is 63629-8362, listed by Bryant Ranch Prepack.