01 1Apotex Inc.
01 1ADEFOVIR DIPIVOXIL
01 1Canada
NDC Package Code : 49867-0074
Start Marketing Date : 2012-12-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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A Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12), including repackagers and relabelers. The FDA regulates Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) supplier is an individual or a company that provides Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) active pharmaceutical ingredient (API) or Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) finished formulations upon request. The Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) suppliers may include Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) API manufacturers, exporters, distributors and traders.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) suppliers with NDC on PharmaCompass.
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