FDA Orange Book
Generic for Medrol
Medrol contains methylprednisolone. 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 Medrol is methylprednisolone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Medrol products the Orange Book lists.
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Medrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| enema, rectal | 40MG/BOT | Discontinued | None | 0 | None |
| tablet, oral | 16MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 24MG | Discontinued | None | 0 | None |
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 32MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 8MG | Marketed (Rx) | AB | 2 | AB |
NDA 018102, 011153, 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 methylprednisolone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 040232 | AB (A-rated, therapeutically equivalent) | October 16, 1997 | 4MG |
| SANDOZ INC | 040194 | AB (A-rated, therapeutically equivalent) | October 31, 1997 | 4MG |
| PH HEALTH LTD | 040183 | AB (A-rated, therapeutically equivalent) | December 22, 1998 | 4MG |
| JUBILANT CADISTA PHARMACEUTICALS INC | 040189 | AB (A-rated, therapeutically equivalent) | July 20, 2007 | 16MG, 32MG, 4MG, 8MG |
| ZYDUS PHARMACEUTICALS USA INC | 206751 | AB (A-rated, therapeutically equivalent) | April 23, 2018 | 16MG, 32MG, 4MG, 8MG |
| TIANJIN TIANYAO PHARMACEUTICALS CO LTD | 204072 | AB (A-rated, therapeutically equivalent) | May 14, 2018 | 4MG |
Medrol NDC codes
Questions
Is there a generic for Medrol?
Yes. The generic name for Medrol is methylprednisolone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Medrol products the Orange Book lists.
What is the generic name for Medrol?
The active ingredient in Medrol is methylprednisolone, 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.