FDA Orange Book
Generic for Paracort
Paracort 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 Paracort is prednisone. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Paracort products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Discontinued | None | 11 | AB |
NDA 010962, held by PARKE DAVIS DIV WARNER LAMBERT 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 |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | 089247 | AB (A-rated, therapeutically equivalent) | December 4, 1985 | 5MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 040362 | AB (A-rated, therapeutically equivalent) | August 29, 2001 | 5MG |
| PH HEALTH LTD | 040256 | AB (A-rated, therapeutically equivalent) | July 12, 2002 | 5MG |
| NOVITIUM PHARMA LLC | 211575 | AB (A-rated, therapeutically equivalent) | November 15, 2019 | 5MG |
| AMNEAL EU LTD | 213385 | AB (A-rated, therapeutically equivalent) | June 16, 2020 | 5MG |
| STRIDES PHARMA GLOBAL PTE LTD | 208412 | AB (A-rated, therapeutically equivalent) | November 20, 2020 | 5MG |
| AUROBINDO PHARMA LTD | 215672 | AB (A-rated, therapeutically equivalent) | March 28, 2022 | 5MG |
| PHARMAZONE | 212629 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 5MG |
| HIKMA PHARMACEUTICALS USA INC | 080352 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| MYLAN PHARMACEUTICALS INC | 083677 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
| WATSON LABORATORIES INC | 080356 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Paracort?
Yes. The generic name for Paracort is prednisone. 11 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 Paracort?
The active ingredient in Paracort 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.