01 1B.V. KATWIJK CHEMIE
02 1Fagron Inc
03 1Harman Finochem Limited
04 1LETCO MEDICAL, LLC
05 1Pharmacia and Upjohn Company LLC
06 1Professional Compounding Centers of America
07 1Professional Compounding Centers of America dba PCCA
08 2RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA
09 1Spectrum Laboratory Products, Inc.
10 1Swati Spentose Private Limited
01 3PHENYTOIN
02 7Phenytoin
03 1Phenytoin Micronized
01 2India
02 2Italy
03 2Netherlands
04 3U.S.A
05 2United Kingdom
NDC Package Code : 51552-0553
Start Marketing Date : 1998-04-01
End Marketing Date : 2025-09-18
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 17349-0007
Start Marketing Date : 1984-06-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62991-1691
Start Marketing Date : 2011-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-1216
Start Marketing Date : 2013-06-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0300
Start Marketing Date : 2023-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 0009-0488
Start Marketing Date : 2013-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12711-4445
Start Marketing Date : 1982-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 12711-4444
Start Marketing Date : 2009-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 49452-5340
Start Marketing Date : 1986-05-01
End Marketing Date : 2026-07-19
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52119-007
Start Marketing Date : 2012-08-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Phenytoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenytoin, including repackagers and relabelers. The FDA regulates Phenytoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenytoin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Phenytoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenytoin supplier is an individual or a company that provides Phenytoin active pharmaceutical ingredient (API) or Phenytoin finished formulations upon request. The Phenytoin suppliers may include Phenytoin API manufacturers, exporters, distributors and traders.
click here to find a list of Phenytoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Phenytoin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Phenytoin 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 Phenytoin 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 Phenytoin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenytoin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Phenytoin suppliers with NDC on PharmaCompass.
We have 9 companies offering Phenytoin
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