FDA Orange Book
Generic for Daliresp
Daliresp contains roflumilast. 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 Daliresp is roflumilast. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Daliresp products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MCG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 500MCG | Marketed (Rx) | AB | 9 | AB |
NDA 022522, 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 roflumilast
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PRINSTON PHARMACEUTICAL INC | 208299 | AB (A-rated, therapeutically equivalent) | May 10, 2022 | 500MCG |
| MSN LABORATORIES PRIVATE LTD | 208256 | AB (A-rated, therapeutically equivalent) | September 7, 2022 | 250MCG, 500MCG |
| ALKEM LABORATORIES LTD | 212490 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 250MCG, 500MCG |
| HETERO LABS LTD UNIT III | 208213 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 250MCG, 500MCG |
| MICRO LABS LTD | 208180 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 250MCG, 500MCG |
| ZYDUS PHARMACEUTICALS USA INC | 208303 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 250MCG, 500MCG |
| STRIDES PHARMA GLOBAL PTE LTD | 208247 | AB (A-rated, therapeutically equivalent) | June 20, 2023 | 250MCG, 500MCG |
| PHARMAZONE | 208236 | AB (A-rated, therapeutically equivalent) | October 19, 2023 | 250MCG, 500MCG |
| AUROBINDO PHARMA LTD | 213298 | AB (A-rated, therapeutically equivalent) | January 31, 2025 | 250MCG, 500MCG |
Daliresp NDC codes
Questions
Is there a generic for Daliresp?
Yes. The generic name for Daliresp is roflumilast. 9 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 Daliresp?
The active ingredient in Daliresp is roflumilast, 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.