FDA Orange Book
Generic for Hectorol
Hectorol contains doxercalciferol. 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 Hectorol is doxercalciferol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 5 Hectorol products the Orange Book lists.
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Hectorol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.5MCG | Discontinued | None | 2 | AB |
| capsule, oral | 1MCG | Discontinued | None | 2 | AB |
| capsule, oral | 2.5MCG | Discontinued | None | 2 | AB |
| injectable, injection | 2MCG/ML (2MCG/ML) | Discontinued | None | 0 | None |
| injectable, injection | 4MCG/2ML (2MCG/ML) | Discontinued | None | 4 | AP |
NDA 020862, 021027, held by SANOFI GENZYME. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxercalciferol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 091333 | AP (A-rated, therapeutically equivalent) | May 5, 2014 | 4MCG/2ML (2MCG/ML) |
| RISING PHARMA HOLDINGS INC | 201518 | AB (A-rated, therapeutically equivalent) | September 9, 2016 | 0.5MCG, 1MCG, 2.5MCG |
| GLAND PHARMA LTD | 210452 | AP (A-rated, therapeutically equivalent) | September 26, 2019 | 4MCG/2ML (2MCG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 211670 | AP (A-rated, therapeutically equivalent) | February 7, 2020 | 4MCG/2ML (2MCG/ML) |
| AVET PHARMACEUTICALS INC | 205360 | AB (A-rated, therapeutically equivalent) | September 15, 2020 | 0.5MCG, 1MCG, 2.5MCG |
| ALEMBIC PHARMACEUTICALS LTD | 215810 | AP (A-rated, therapeutically equivalent) | June 15, 2023 | 4MCG/2ML (2MCG/ML) |
Hectorol exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | June 11, 2028 | 020862 |
Questions
Is there a generic for Hectorol?
Yes. The generic name for Hectorol is doxercalciferol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 5 Hectorol products the Orange Book lists.
What is the generic name for Hectorol?
The active ingredient in Hectorol is doxercalciferol, 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.