FDA Orange Book
Generic for Pulmicort Respules
Pulmicort Respules 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 Pulmicort Respules is budesonide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Pulmicort Respules products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, inhalation | 0.25MG/2ML | Marketed (Rx) | AN | 5 | AN |
| suspension, inhalation | 0.5MG/2ML | Marketed (Rx) | AN | 7 | AN |
| suspension, inhalation | 1MG/2ML | Marketed (Rx) | AN | 3 | AN |
NDA 020929, held by ASTRAZENECA PHARMACEUTICALS LP. 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077519 | AN (A-rated, therapeutically equivalent) | November 18, 2008 | 0.25MG/2ML, 0.5MG/2ML |
| NEPHRON PHARMACEUTICALS CORPORATION | 078202 | AN (A-rated, therapeutically equivalent) | March 30, 2009 | 0.25MG/2ML, 0.5MG/2ML |
| IMPAX LABORATORIES INC | 078404 | AN (A-rated, therapeutically equivalent) | July 31, 2012 | 0.25MG/2ML, 0.5MG/2ML |
| TEVA PHARMACEUTICALS USA | 204548 | AN (A-rated, therapeutically equivalent) | March 8, 2016 | 1MG/2ML |
| CIPLA LTD | 205710 | AN (A-rated, therapeutically equivalent) | November 16, 2017 | 0.25MG/2ML, 0.5MG/2ML, 1MG/2ML |
| LUPIN INC | 210897 | AN (A-rated, therapeutically equivalent) | November 9, 2018 | 0.5MG/2ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 211922 | AN (A-rated, therapeutically equivalent) | April 14, 2021 | 0.25MG/2ML, 0.5MG/2ML, 1MG/2ML |
| EUGIA PHARMA SPECIALITIES LTD | 216667 | AN (A-rated, therapeutically equivalent) | November 29, 2023 | 0.5MG/2ML |
Pulmicort Respules NDC codes
Questions
Is there a generic for Pulmicort Respules?
Yes. The generic name for Pulmicort Respules is budesonide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Pulmicort Respules?
The active ingredient in Pulmicort Respules 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 Respules and Budesonide
- 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 FlexhalerFDA Orange Book
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- Corticosteroids listFDA drug class
- NDC 0186-1988Pulmicort Respules NDC record
- NDC 0186-1989Pulmicort Respules NDC record
- NDC 0186-1990Pulmicort Respules NDC record