FDA Orange Book
Generic for Rocaltrol
Rocaltrol 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 Rocaltrol is calcitriol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Rocaltrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.25MCG | Marketed (Rx) | AB | 6 | AB |
| capsule, oral | 0.5MCG | Marketed (Rx) | AB | 5 | AB |
| solution, oral | 1MCG/ML | Marketed (Rx) | AA | 3 | AA |
NDA 018044, 021068, held by ESJAY PHARMA LLC. 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 075765 | AB (A-rated, therapeutically equivalent) | October 12, 2001 | 0.25MCG, 0.5MCG |
| HIKMA PHARMACEUTICALS USA INC | 076242 | AA (A-rated, therapeutically equivalent) | July 18, 2003 | 1MCG/ML |
| HIKMA PHARMACEUTICALS USA INC | 076917 | AB (A-rated, therapeutically equivalent) | March 27, 2006 | 0.25MCG |
| BIONPHARMA INC | 091174 | AB (A-rated, therapeutically equivalent) | May 24, 2013 | 0.25MCG, 0.5MCG |
| ONESOURCE SPECIALTY PTE LTD | 091356 | AB (A-rated, therapeutically equivalent) | December 12, 2014 | 0.25MCG, 0.5MCG |
| AMNEAL PHARMACEUTICALS | 203289 | AB (A-rated, therapeutically equivalent) | June 14, 2017 | 0.25MCG, 0.5MCG |
| RISING PHARMA HOLDINGS INC | 209798 | AA (A-rated, therapeutically equivalent) | November 21, 2018 | 1MCG/ML |
| ANDA REPOSITORY LLC | 203973 | AA (A-rated, therapeutically equivalent) | July 28, 2023 | 1MCG/ML |
| HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD | 219796 | AB (A-rated, therapeutically equivalent) | February 27, 2026 | 0.25MCG, 0.5MCG |
Rocaltrol NDC codes
Questions
Is there a generic for Rocaltrol?
Yes. The generic name for Rocaltrol is calcitriol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Rocaltrol?
The active ingredient in Rocaltrol 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.