FDA Orange Book
Generic for Depo-Medrol
Depo-Medrol contains methylprednisolone acetate. 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 Depo-Medrol is methylprednisolone acetate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Depo-Medrol products the Orange Book lists.
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Depo-Medrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 20MG/ML | Marketed (Rx) | None | 0 | None |
| injectable, injection | 40MG/ML | Marketed (Rx) | AB | 10 | AB |
| injectable, injection | 80MG/ML | Marketed (Rx) | AB | 11 | AB |
NDA 011757, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylprednisolone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EMERGE BIOSCIENCE PTE LTD | 040557 | AB (A-rated, therapeutically equivalent) | February 23, 2005 | 40MG/ML, 80MG/ML |
| SANDOZ INC | 040719 | AB (A-rated, therapeutically equivalent) | January 29, 2009 | 40MG/ML, 80MG/ML |
| SANDOZ INC | 040794 | AB (A-rated, therapeutically equivalent) | March 5, 2009 | 40MG/ML, 80MG/ML |
| SAGENT PHARMACEUTICALS INC | 201835 | AB (A-rated, therapeutically equivalent) | June 27, 2018 | 40MG/ML, 80MG/ML |
| AMNEAL EU LTD | 210043 | AB (A-rated, therapeutically equivalent) | May 20, 2019 | 40MG/ML, 80MG/ML |
| PH HEALTH LTD | 214297 | AB (A-rated, therapeutically equivalent) | January 21, 2022 | 40MG/ML, 80MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 211930 | AB (A-rated, therapeutically equivalent) | April 13, 2023 | 40MG/ML, 80MG/ML |
| WILSHIRE PHARMACEUTICALS INC | 214870 | AB (A-rated, therapeutically equivalent) | May 10, 2023 | 40MG/ML, 80MG/ML |
| AMNEAL EU LTD | 216502 | AB (A-rated, therapeutically equivalent) | November 3, 2023 | 40MG/ML, 80MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 219145 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | 80MG/ML |
| CAPLIN STERILES LTD | 220556 | AB (A-rated, therapeutically equivalent) | January 26, 2026 | 40MG/ML, 80MG/ML |
Depo-Medrol NDC codes
Questions
Is there a generic for Depo-Medrol?
Yes. The generic name for Depo-Medrol is methylprednisolone acetate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Depo-Medrol products the Orange Book lists.
What is the generic name for Depo-Medrol?
The active ingredient in Depo-Medrol is methylprednisolone acetate, 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.