FDA Orange Book
Generic for Calcijex
Calcijex contains calcitriol. 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 Calcijex is calcitriol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Calcijex products the Orange Book lists.
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Calcijex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.001MG/ML | Discontinued | None | 2 | AP |
| injectable, injection | 0.002MG/ML | Discontinued | None | 0 | None |
NDA 018874, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic calcitriol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LONG GROVE PHARMACEUTICALS LLC | 078066 | AP (A-rated, therapeutically equivalent) | January 29, 2008 | 0.001MG/ML |
| GLAND PHARMA LTD | 211030 | AP (A-rated, therapeutically equivalent) | February 3, 2020 | 0.001MG/ML |
Questions
Is there a generic for Calcijex?
Yes. The generic name for Calcijex is calcitriol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Calcijex products the Orange Book lists.
What is the generic name for Calcijex?
The active ingredient in Calcijex is calcitriol, 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.