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FDA Therapeutic Equivalency Codes: How Laws Determine Which Generic Drugs Can Be Substituted

FDA Therapeutic Equivalency Codes: How Laws Determine Which Generic Drugs Can Be Substituted

  • Robin Tudge
  • February 8, 2026
  • 13 Comments

FDA therapeutic equivalency codes determine whether generic drugs can be legally substituted for brand-name versions. Learn how the Orange Book system works, what A and B codes mean, and why they save billions in healthcare costs.

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