FDA Orange Book
Generic for Advair Diskus 100/50
Advair Diskus 100/50 contains fluticasone propionate and salmeterol. 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 Advair Diskus 100/50 is fluticasone propionate and salmeterol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Advair Diskus 100/50 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.1MG/INH;EQ 0.05MG BASE/INH | Marketed (Rx) | AB | 5 | AB |
NDA 021077, held by GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluticasone propionate and salmeterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 208891 | AB (A-rated, therapeutically equivalent) | January 30, 2019 | 0.1MG/INH;EQ 0.05MG BASE/INH |
| HIKMA PHARMACEUTICALS USA INC | 203433 | AB (A-rated, therapeutically equivalent) | December 17, 2020 | 0.1MG/INH;EQ 0.05MG BASE/INH |
| TEVA PHARMACEUTICALS USA INC | 213948 | AB (A-rated, therapeutically equivalent) | December 13, 2021 | 0.1MG/INH;EQ 0.05MG BASE/INH |
| RESPIRENT PHARMACEUTICALS CO LTD | 214464 | AB (A-rated, therapeutically equivalent) | January 12, 2026 | 0.1MG/INH;EQ 0.05MG BASE/INH |
| CIPLA LTD | 213087 | AB (A-rated, therapeutically equivalent) | July 27, 2026 | 0.1MG/INH;EQ 0.05MG BASE/INH |
Advair Diskus 100/50 NDC codes
Questions
Is there a generic for Advair Diskus 100/50?
Yes. The generic name for Advair Diskus 100/50 is fluticasone propionate and salmeterol. 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 Advair Diskus 100/50?
The active ingredient in Advair Diskus 100/50 is fluticasone propionate and salmeterol, 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.