FDA Orange Book
Generic for Deltasone
Deltasone contains prednisone. 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 Deltasone is prednisone. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Deltasone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 11 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 6 | AB |
| tablet, oral | 20MG | Discontinued | None | 12 | BX, AB |
| tablet, oral | 50MG | Discontinued | None | 5 | AB |
| tablet, oral | 5MG | Discontinued | None | 11 | AB |
NDA 009986, held by PHARMACIA AND UPJOHN CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prednisone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 083677 | AB (A-rated, therapeutically equivalent) | December 4, 1985 | 10MG, 20MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 089247 | AB (A-rated, therapeutically equivalent) | December 4, 1985 | 10MG, 20MG, 5MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 040362 | AB (A-rated, therapeutically equivalent) | August 29, 2001 | 10MG, 2.5MG, 20MG, 50MG, 5MG |
| PH HEALTH LTD | 040256 | AB (A-rated, therapeutically equivalent) | July 12, 2002 | 10MG, 5MG |
| PH HEALTH LTD | 040392 | AB (A-rated, therapeutically equivalent) | February 12, 2003 | 20MG |
| PH HEALTH LTD | 040581 | AB (A-rated, therapeutically equivalent) | December 21, 2004 | 2.5MG |
| NOVITIUM PHARMA LLC | 211575 | AB (A-rated, therapeutically equivalent) | November 15, 2019 | 10MG, 2.5MG, 20MG, 50MG, 5MG |
| AMNEAL EU LTD | 213385 | AB (A-rated, therapeutically equivalent) | June 16, 2020 | 5MG |
| AMNEAL EU LTD | 213386 | AB (A-rated, therapeutically equivalent) | June 24, 2020 | 10MG, 20MG |
| STRIDES PHARMA GLOBAL PTE LTD | 208412 | AB (A-rated, therapeutically equivalent) | February 11, 2021 | 10MG, 2.5MG, 20MG, 50MG, 5MG |
| AUROBINDO PHARMA LTD | 215672 | AB (A-rated, therapeutically equivalent) | March 28, 2022 | 10MG, 2.5MG, 20MG, 50MG, 5MG |
| PHARMAZONE | 212629 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 10MG, 20MG, 5MG |
| HIKMA PHARMACEUTICALS USA INC | 080352 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG, 2.5MG, 20MG, 50MG, 5MG |
| WATSON LABORATORIES INC | 085162 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 10MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 084275 | BX (B-rated, not considered equivalent) | Approved Prior to Jan 1, 1982 | 20MG |
| WATSON LABORATORIES INC | 085161 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 20MG |
| WATSON LABORATORIES INC | 080356 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Deltasone?
Yes. The generic name for Deltasone is prednisone. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Deltasone?
The active ingredient in Deltasone is prednisone, 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.