FDA Orange Book
Generic for Solu-Cortef
Solu-Cortef contains hydrocortisone. 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-Cortef is hydrocortisone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Solu-Cortef products the Orange Book lists.
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Solu-Cortef products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 100MG BASE/VIAL | Marketed (Rx) | AP | 3 | AP |
| injectable, injection | EQ 1GM BASE/VIAL | Marketed (Rx) | None | 0 | None |
| injectable, injection | EQ 250MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 009866, 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 hydrocortisone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 214050 | AP (A-rated, therapeutically equivalent) | September 5, 2024 | EQ 100MG BASE/VIAL |
| APOTEX INC | 219856 | AP (A-rated, therapeutically equivalent) | February 5, 2026 | EQ 100MG BASE/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 217191 | AP (A-rated, therapeutically equivalent) | May 7, 2026 | EQ 100MG BASE/VIAL |
Solu-Cortef NDC codes
Questions
Is there a generic for Solu-Cortef?
Yes. The generic name for Solu-Cortef is hydrocortisone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Solu-Cortef products the Orange Book lists.
What is the generic name for Solu-Cortef?
The active ingredient in Solu-Cortef is hydrocortisone, 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.
More on Solu-Cortef and Hydrocortisone
- What is Solu-Cortef used for?FDA label uses
- Is Solu-Cortef a controlled substance?Federal schedule
- What is Hydrocortisone used for?FDA label uses
- Is Hydrocortisone a controlled substance?Federal schedule
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- Corticosteroids listFDA drug class
- NDC 0009-0005Solu-Cortef NDC record
- NDC 0009-0011Solu-Cortef NDC record
- NDC 0009-0013Solu-Cortef NDC record