FDA Orange Book
Generic for Parlodel
Parlodel contains bromocriptine. 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 Parlodel is bromocriptine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Parlodel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 5MG BASE | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | EQ 2.5MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 017962, held by ESJAY PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bromocriptine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 074631 | AB (A-rated, therapeutically equivalent) | January 13, 1998 | EQ 2.5MG BASE |
| MYLAN PHARMACEUTICALS INC | 077226 | AB (A-rated, therapeutically equivalent) | April 4, 2005 | EQ 5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 078899 | AB (A-rated, therapeutically equivalent) | July 30, 2008 | EQ 5MG BASE |
| PADAGIS US LLC | 077646 | AB (A-rated, therapeutically equivalent) | October 1, 2008 | EQ 2.5MG BASE |
Parlodel NDC codes
Questions
Is there a generic for Parlodel?
Yes. The generic name for Parlodel is bromocriptine. 4 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 Parlodel?
The active ingredient in Parlodel is bromocriptine, 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.