FDA Orange Book
Generic for Limbitrol
Limbitrol contains chlordiazepoxide and amitriptyline. 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 Limbitrol is chlordiazepoxide and amitriptyline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Limbitrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 12.5MG BASE;5MG | Discontinued | None | 1 | None |
NDA 016949, 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 chlordiazepoxide and amitriptyline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 071297 | None (No TE code listed) | December 10, 1986 | EQ 12.5MG BASE;5MG |
Questions
Is there a generic for Limbitrol?
Yes. The generic name for Limbitrol is chlordiazepoxide and amitriptyline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Limbitrol?
The active ingredient in Limbitrol is chlordiazepoxide and amitriptyline, 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.