FDA Orange Book

Generic for Moban

Moban contains molindone. 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 Moban is molindone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 3 of the 9 Moban products the Orange Book lists.

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Moban products in the Orange Book

Moban products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral10MGDiscontinuedNone0None
capsule, oral25MGDiscontinuedNone0None
capsule, oral5MGDiscontinuedNone0None
concentrate, oral20MG/MLDiscontinuedNone0None
tablet, oral100MGDiscontinuedNone0None
tablet, oral10MGDiscontinuedNone1None
tablet, oral25MGDiscontinuedNone1None
tablet, oral50MGDiscontinuedNone0None
tablet, oral5MGDiscontinuedNone1None

NDA 017111, 017938, held by CHARTWELL RX SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic molindone

Approved generic versions of Moban
CompanyANDATE codeApprovedStrengths
EPIC PHARMA LLC090453None (No TE code listed)March 20, 201510MG, 25MG, 5MG

Questions

Is there a generic for Moban?

Yes. The generic name for Moban is molindone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 3 of the 9 Moban products the Orange Book lists.

What is the generic name for Moban?

The active ingredient in Moban is molindone, 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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