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U.S. Department of Health and Human Services

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Are generic drugs the same as brand name drugs?

Federal law requires that companies seeking approval for generic versions of approved drugs must demonstrate that their products are the same as the original brand name drug in terms of

  • active ingredients
  • strength
  • dosage form
  • route of administration
  • label

In addition, the company must demonstrate that the generic form is absorbed and distributed to the part of the body at which it has its effect at acceptably similar levels to the brand name drug. And all drugs—new or generic, in clinical trials or approved, prescription or over-the-counter—must be manufactured under controlled conditions that assure product quality.

FDA firmly believes that generic drug products that have gone through the approval process can be used with the full expectation that consumers will receive the same benefits from generics as they do from brand name equivalents.

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