FDA Orange Book

Generic for Solu-Medrol

Solu-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 Solu-Medrol is methylprednisolone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Solu-Medrol products in the Orange Book

Solu-Medrol products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	EQ 125MG BASE/VIAL	Marketed (Rx)	AP	5	AP
injectable, injection	EQ 1GM BASE/VIAL	Marketed (Rx)	AP	4	AP
injectable, injection	EQ 2GM BASE/VIAL	Marketed (Rx)	AP	2	AP
injectable, injection	EQ 40MG BASE/VIAL	Marketed (Rx)	AP	5	AP
injectable, injection	EQ 500MG BASE/VIAL	Marketed (Rx)	AP	3	AP

NDA 011856, 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

Approved generic versions of Solu-Medrol
Company	ANDA	TE code	Approved	Strengths
FRESENIUS KABI USA LLC	040583	AP (A-rated, therapeutically equivalent)	July 30, 2004	EQ 125MG BASE/VIAL, EQ 40MG BASE/VIAL
FRESENIUS KABI USA LLC	040612	AP (A-rated, therapeutically equivalent)	August 12, 2004	EQ 1GM BASE/VIAL
SAGENT PHARMACEUTICALS INC	040888	AP (A-rated, therapeutically equivalent)	July 18, 2011	EQ 125MG BASE/VIAL, EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 40MG BASE/VIAL, EQ 500MG BASE/VIAL
HIKMA FARMACEUTICA PORTUGAL SA	202691	AP (A-rated, therapeutically equivalent)	February 16, 2016	EQ 1GM BASE/VIAL, EQ 500MG BASE/VIAL
AMNEAL EU LTD	207549	AP (A-rated, therapeutically equivalent)	November 9, 2016	EQ 125MG BASE/VIAL, EQ 40MG BASE/VIAL
TIANJIN KINGYORK PHARMACEUTICALS CO LTD	212396	AP (A-rated, therapeutically equivalent)	April 20, 2021	EQ 125MG BASE/VIAL, EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 40MG BASE/VIAL, EQ 500MG BASE/VIAL
HIKMA FARMACEUTICA PORTUGAL SA	203125	AP (A-rated, therapeutically equivalent)	September 26, 2022	EQ 125MG BASE/VIAL, EQ 40MG BASE/VIAL

Solu-Medrol NDC codes

Questions

Is there a generic for Solu-Medrol?

Yes. The generic name for Solu-Medrol is methylprednisolone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Solu-Medrol?

The active ingredient in Solu-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.