PTCB - Therapeutic Equivalence Codes (FDA Codes)

A

Drugs products that are considered to be therapeutically equivalent to other pharmaceutically equivalent products.

AA

Products not representing bioequivalence problems in conventional dosage forms.

AB

Products meeting necessary bioequivalence requirements

AO

Injectable oil solutions that are considered therapeutically equivalent

AP

Injectable aqueous solutions

AT

Topical products that are considered therapeutically equivalent to other pharmaeutically equivalent products

B Codes

Drug products that the FDA does not consider at this time to be therapeutically equivalent to other pharmaceutically equivalent products

BC

Controlled release tablets, controlled capsuls, 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 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

BT

Topical products

BX

Insufficient data: these products are presumed to be therapeutically not equivalent until adequate information becomes available for full evaluation for therapeutic equivalent