FDA Orange Book
Is there a generic for Pulmicort Flexhaler?
Pulmicort Flexhaler 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pulmicort Flexhaler (budesonide).
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Pulmicort Flexhaler products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, metered, inhalation | 0.08MG/INH | Marketed (Rx) | None | 0 | None |
| powder, metered, inhalation | 0.16MG/INH | Marketed (Rx) | None | 0 | None |
NDA 021949, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pulmicort Flexhaler NDC codes
Questions
Is there a generic for Pulmicort Flexhaler?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pulmicort Flexhaler (budesonide).
What is the generic name for Pulmicort Flexhaler?
The active ingredient in Pulmicort Flexhaler 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.
More on Pulmicort Flexhaler and Budesonide
- What is Pulmicort Flexhaler used for?FDA label uses
- Is Pulmicort Flexhaler a controlled substance?Federal schedule
- What is Budesonide used for?FDA label uses
- Is Budesonide a controlled substance?Federal schedule
- Generic for UcerisFDA Orange Book
- Generic for Entocort ECFDA Orange Book
- Generic for TarpeyoFDA Orange Book
- Generic for Pulmicort RespulesFDA Orange Book
- Generic for EohiliaFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 50090-6796Pulmicort Flexhaler NDC record