NDC 63629-7422 Colchicine
Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Product Packages
NDC Code 63629-7422-1
Package Description: 30 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-2
Package Description: 10 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-3
Package Description: 8 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-4
Package Description: 90 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-5
Package Description: 60 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-6
Package Description: 3 CAPSULE in 1 BOTTLE
NDC Code 63629-7422-7
Package Description: 20 CAPSULE in 1 BOTTLE
Product Details
What is NDC 63629-7422?
What are the uses for Colchicine?
What are Colchicine Active Ingredients?
- COLCHICINE .6 mg/1 - A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. Its primary therapeutic use is in the treatment of gout, but it has been used also in the therapy of familial Mediterranean fever (PERIODIC DISEASE).
Which are Colchicine UNII Codes?
The UNII codes for the active ingredients in this product are:
- COLCHICINE (UNII: SML2Y3J35T)
- COLCHICINE (UNII: SML2Y3J35T) (Active Moiety)
Which are Colchicine Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- WATER (UNII: 059QF0KO0R)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
What is the NDC to RxNorm Crosswalk for Colchicine?
- RxCUI: 1550940 - colchicine 0.6 MG Oral Capsule
Which are the Pharmacologic Classes for Colchicine?
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Patient Education
Colchicine
Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults. Colchicine (Colcrys) is also used to relieve the pain of gout attacks when they occur. Colchicine (Colcrys) is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine is not a pain reliever and cannot be used to treat pain that is not caused by gout or FMF. Colchicine is in a class of medications called anti-gout agents. It works by stopping the natural processes that cause swelling and other symptoms of gout and FMF.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".