FDA Orange Book
Generic for Entocort EC
Entocort EC contains budesonide. 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 Entocort EC is budesonide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Entocort EC products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | 3MG | Marketed (Rx) | AB | 5 | AB |
NDA 021324, held by PADAGIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic budesonide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 090410 | AB (A-rated, therapeutically equivalent) | May 16, 2011 | 3MG |
| DR REDDYS LABORATORIES SA | 206623 | AB (A-rated, therapeutically equivalent) | April 8, 2016 | 3MG |
| RISING PHARMA HOLDINGS INC | 207367 | AB (A-rated, therapeutically equivalent) | April 7, 2017 | 3MG |
| ZYDUS PHARMACEUTICALS USA INC | 206134 | AB (A-rated, therapeutically equivalent) | May 4, 2017 | 3MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 206200 | AB (A-rated, therapeutically equivalent) | July 31, 2017 | 3MG |
Entocort EC NDC codes
Questions
Is there a generic for Entocort EC?
Yes. The generic name for Entocort EC is budesonide. 5 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 Entocort EC?
The active ingredient in Entocort EC is budesonide, 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.