FDA Orange Book

Generic for Tridil

Tridil contains nitroglycerin. 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 Tridil is nitroglycerin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Tridil products the Orange Book lists.

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Tridil products in the Orange Book

Tridil products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection0.5MG/MLDiscontinuedNone0None
injectable, injection5MG/MLDiscontinuedNone1None

NDA 018537, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nitroglycerin

Approved generic versions of Tridil
CompanyANDATE codeApprovedStrengths
AMERICAN REGENT INC072034None (No TE code listed)May 24, 19885MG/ML

Questions

Is there a generic for Tridil?

Yes. The generic name for Tridil is nitroglycerin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Tridil products the Orange Book lists.

What is the generic name for Tridil?

The active ingredient in Tridil is nitroglycerin, 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.

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