FDA Orange Book · active-ingredient family
Ergocalciferol
Ergocalciferol: 1 brand, 13 generics; first approved May 20, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- DRISDOLRLDESJAY PHARMANDA 003444—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Rx AA
Generic (ANDA) products (13)
Abbreviated applications
- ERGOCALCIFEROLPURACAP PHARM LLCANDA 2042762018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Rx AA - ERGOCALCIFEROLRSONESOURCE SPECIALTYANDA 0904552010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Rx AA - ERGOCALCIFEROLSIGMAPHARM LABS LLCANDA 0910042010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - ERGOCALCIFEROLSUN PHARM INDS INCANDA 0408652009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - ERGOCALCIFEROLCHARTWELL RXANDA 0408332009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Rx AA - LILLYANDA 080884—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - BIONPHARMAANDA 080704—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Rx AA - CHARTWELL MOLECULARANDA 080825—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - CHASE CHEMANDA 080747—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - EVERYLIFEANDA 080956—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - IMPAX LABSANDA 080951—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - VITARINEANDA 084053—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued — - WEST WARDANDA 083102—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50,000 IU CAPSULE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
17 yr 6 mo ago
Most recent approval
7 yr 10 mo ago
Approvals span 2009–2018 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Ergocalciferol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
