Generics Code and Therapeutic Definitions

"A" codes are drug products that are considered by the FDA to be therapeutically equivalent to other pharmaceutically equivalent products
 AA     Products not presenting bioequivalence problems in conventional dosage forms
 AB     Products meeting necessary bioequivalence requirements
 AP     Injectable aqueous solutions
 AT     Topical products that are considered therapeutically equivalent to other pharmacetucally equivalent products
 AO     Injectable oil solutions that are considered therapeutically equivalent to other pharmaceutically equivalent products
"B" codes are drug products that the FDA does not at this time consider to be therapeutically equivalent to other pharmaceutically equivalent products
 BC     Controlled-release tablets, controlled-release capsules, and controlled-release injectables (controlled-release products for which such bioequivalence data are available have been coded AB)
 BD     Active ingredients and dosage forms with documented bioequivalence problems
 BE     Enteric-coated oral dosage forms (enteric-coated oral dosage forms for which bioequivalence data are available are coded AB)
 BP     Active ingredients and dosage forms with POTENTIAL bioequivalence problems
 BR     Suppositories or enemas for systemic use
 BS     Products having standard deficiencies (if the drug standards for an active ingredient in a particular dosage form are found by FDA to be deficient so as to prevent an FDA evaluation of either pharmaceutical or therapeutic equivalence, all drug products containing that active ingredient in that dosage form are coded BS. For example, if the standards permit a wide variation in pharmacologically active components of the active ingredient such that pharmaceutical equivalence is in question, all products containing that active ingredient in that dosage form are coded BS.)
 BT     Topical products
 BX     Insufficient data - These products are presumed to be therapeutically inequivalent until adequate information becomes available for full evaluation of therapeutic equivalence

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