FDA Orange Book
Generic for Drisdol
Drisdol contains ergocalciferol. 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 Drisdol is ergocalciferol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Drisdol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 50,000 IU | Marketed (Rx) | AA | 4 | AA |
NDA 003444, 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 ergocalciferol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 040833 | AA (A-rated, therapeutically equivalent) | May 20, 2009 | 50,000 IU |
| ONESOURCE SOFTGELS PTE LTD | 090455 | AA (A-rated, therapeutically equivalent) | August 3, 2010 | 50,000 IU |
| PURACAP PHARMACEUTICAL LLC | 204276 | AA (A-rated, therapeutically equivalent) | December 7, 2018 | 50,000 IU |
| BIONPHARMA INC | 080704 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 50,000 IU |
Drisdol NDC codes
Questions
Is there a generic for Drisdol?
Yes. The generic name for Drisdol is ergocalciferol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Drisdol?
The active ingredient in Drisdol is ergocalciferol, 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.