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In the U.S., start with your pharmacist or prescriber and confirm that any proposed generic matches the prescription’s active ingredient, strength, dosage form, and route. An FDA-approved generic must also meet bioequivalence requirements; a similar drug name or a different formulation is not enough to establish that it can replace your medicine.
How to check for a suitable generic
- Gather the exact prescription details. Use the label or prescription record to identify the active ingredient, strength, dosage form (such as a tablet or capsule), and route (such as oral or topical). Ask your pharmacist or prescriber to verify these details if anything is unclear.
- Ask whether an FDA-approved generic exists for that exact product. Not every prescription drug necessarily has an available generic. Ask the pharmacist or prescriber whether an approved option is appropriate for your prescription.
- Use the FDA Orange Book as a reference, not as a personal treatment decision. The FDA’s Orange Book provides approved-product and therapeutic-equivalence information. Search and compare the active ingredient, dosage form, strength, and route; then confirm the candidate with your pharmacist or prescriber.
- Discuss personal concerns before switching. Tell the pharmacist or prescriber about allergies, sensitivities, or symptoms that began after a previous switch. Inactive ingredients can differ between products.
- Confirm the actual product and local substitution rules. Have the pharmacist or prescriber check the product being dispensed for this prescription. Rules for pharmacy substitution depend on the medicine and jurisdiction.
What makes a medicine a generic equivalent?
FDA-approved generic drugs have the same active ingredient, strength, dosage form, and route as the reference drug. They must meet bioequivalence requirements and applicable quality and manufacturing standards. FDA says approved generics are expected to provide the same clinical benefit and risks as their brand-name counterparts. Differences in appearance or inactive ingredients do not by themselves mean a generic is inferior.
The FDA Orange Book describes therapeutic equivalents as pharmaceutical equivalents for which bioequivalence has been demonstrated. In the agency’s words, they “can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” See the Orange Book Preface for the agency’s terminology.
Why a similar medicine or formulation may not be interchangeable
A pharmaceutical alternative may contain the same therapeutic moiety yet differ in the amount, dosage form, salt, or ester. That does not automatically make it a therapeutically equivalent generic. For example, finding a product with a related name or a different form does not establish that it can replace the prescribed product. Ask a pharmacist or prescriber to assess the exact products rather than inferring equivalence from a listing.
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Do not change the dose, split or crush a tablet, or switch to another dosage form based only on a product listing. Whether any such change is suitable depends on the particular medicine and prescription.
What to know about inactive ingredients
Generic products may contain different inactive ingredients, such as fillers or coloring agents. FDA says these differences usually do not affect how the medicine works, but they may matter to some people because of an allergy, sensitivity, tolerability concern, or possible effect on absorption. If you suspect a problem, contact your pharmacist or prescriber to review the ingredients and discuss an appropriate option.
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If the prescribed medicine is a biologic
Biologics have a separate category of alternatives called biosimilars; they are not ordinary generics. FDA describes a biosimilar as highly similar to its reference biologic. Some biosimilars are designated interchangeable, but not all are. Pharmacy substitution of interchangeable biosimilars is subject to state pharmacy laws, so ask the pharmacist how the rules apply where you live. See the FDA’s guide to biosimilar and interchangeable biologics.
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If you cannot confirm an exact match, or the candidate differs in strength, dosage form, route, or other prescription details, do not switch on your own. Take the product information to your pharmacist or prescriber and ask them to verify whether it is appropriate. FDA likewise advises patients to discuss generic medicines with a doctor, pharmacist, or other health care provider; its overview is Generic Drug Facts. Availability and substitution requirements depend on the specific medicine and applicable local rules.
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