FDA Orange Book
Generic for Detrol
Detrol contains tolterodine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Detrol is tolterodine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Detrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 6 | AB |
NDA 020771, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tolterodine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 077006 | AB (A-rated, therapeutically equivalent) | February 23, 2015 | 1MG, 2MG |
| MACLEODS PHARMACEUTICALS LTD | 203409 | AB (A-rated, therapeutically equivalent) | August 31, 2015 | 1MG, 2MG |
| RISING PHARMA HOLDINGS INC | 210775 | AB (A-rated, therapeutically equivalent) | December 30, 2019 | 1MG, 2MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 204721 | AB (A-rated, therapeutically equivalent) | January 24, 2020 | 1MG, 2MG |
| UNICHEM LABORATORIES LTD | 205399 | AB (A-rated, therapeutically equivalent) | August 5, 2020 | 1MG, 2MG |
| HETERO LABS LTD UNIT V | 204397 | AB (A-rated, therapeutically equivalent) | August 2, 2021 | 1MG, 2MG |
Detrol NDC codes
Questions
Is there a generic for Detrol?
Yes. The generic name for Detrol is tolterodine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Detrol?
The active ingredient in Detrol is tolterodine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.