FDA Orange Book
Generic for Symbicort
Symbicort contains budesonide and formoterol. 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 Symbicort is budesonide and formoterol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Symbicort products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.08MG/INH;0.0045MG/INH | Marketed (Rx) | AB | 2 | AB |
| aerosol, metered, inhalation | 0.16MG/INH;0.0045MG/INH | Marketed (Rx) | AB | 2 | AB |
NDA 021929, held by ASTRAZENECA LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic budesonide and formoterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 211699 | AB (A-rated, therapeutically equivalent) | March 15, 2022 | 0.08MG/INH;0.0045MG/INH, 0.16MG/INH;0.0045MG/INH |
| TEVA PHARMACEUTICALS USA INC | 212212 | AB (A-rated, therapeutically equivalent) | April 23, 2026 | 0.08MG/INH;0.0045MG/INH, 0.16MG/INH;0.0045MG/INH |
Symbicort NDC codes
Questions
Is there a generic for Symbicort?
Yes. The generic name for Symbicort is budesonide and formoterol. 2 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 Symbicort?
The active ingredient in Symbicort is budesonide and formoterol, 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 Symbicort and Budesonide and Formoterol
- What is Symbicort used for?FDA label uses
- Is Symbicort a controlled substance?Federal schedule
- What is Budesonide and Formoterol used for?FDA label uses
- Is Budesonide and Formoterol a controlled substance?Federal schedule
- Generic for Symbicort AerosphereFDA Orange Book
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- Beta2-Adrenergic Agonists listFDA drug class
- Symbicort Medicare Part D coverageBy plan and state
- NDC 0186-0370Symbicort NDC record
- NDC 0186-0372Symbicort NDC record
- NDC 50090-1403Symbicort NDC record