Is there a generic for Calcitriol?

Yes. The FDA Orange Book lists 19 approved generic (ANDA) applications for Calcitriol, referencing the brand VECTICAL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Calcitriol?

VECTICAL (NDA 022087, GALDERMA LABS LP) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Calcitriol are approved?

Calcitriol is approved in the following dosage forms: capsule, injectable, ointment, solution.

FDA Orange Book · active-ingredient family

Calcitriol

Calcitriol: 4 brands, 19 generics; first approved Sep 25, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 19 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

VECTICALRLDRS
GALDERMA LABS LPNDA 0220872009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3MCG/GM OINTMENT TOPICAL Rx —
ROCALTROLRLDRS
ESJAY PHARMANDA 0210681998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MCG/ML SOLUTION ORAL Rx AA
CALCIJEXRLD
ABBVIENDA 01887419862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
ROCALTROLRLD
ESJAY PHARMANDA 018044—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
0.5MCG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3MCG/GM	OINTMENT	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MCG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB
0.5MCG	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (19)

Abbreviated applications

CALCITRIOL
HUMANWELL PURACAPANDA 21979620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
0.5MCG CAPSULE ORAL Rx AB
CALCITRIOL
ANDA REPOSITORYANDA 2039732023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MCG/ML SOLUTION ORAL Rx AA
CALCITRIOL
GLANDANDA 2110302020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Rx AP
CALCITRIOL
SUN PHARMANDA 20455620192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Discontinued —
0.5MCG CAPSULE ORAL Discontinued —
CALCITRIOL
RISINGANDA 2097982018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MCG/ML SOLUTION ORAL Rx AA
CALCITRIOL
AMNEAL PHARMSANDA 20328920172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MCG CAPSULE ORAL Rx AB
0.25MCG CAPSULE ORAL Rx AB
CALCITRIOL
ONESOURCE SPECIALTYANDA 09135620142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
0.5MCG CAPSULE ORAL Rx AB
CALCITRIOL
BIONPHARMAANDA 09117420132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
0.5MCG CAPSULE ORAL Rx AB
CALCITRIOLRS
LONG GROVE PHARMSANDA 07806620082 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Rx AP
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
HIKMAANDA 0769172006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
CALCITRIOL
SAGENT PHARMSANDA 0771022006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
HOSPIRAANDA 07581620042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
AM REGENTANDA 07574620032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
ROCKWELL MEDCLANDA 0762062003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
HIKMAANDA 0762422003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MCG/ML SOLUTION ORAL Rx AA
CALCITRIOL
TEVA PARENTERALANDA 07582320032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
FRESENIUS MEDCLANDA 07576620032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
FRESENIUS KABI USAANDA 07583620022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.001MG/ML INJECTABLE INJECTION Discontinued —
0.002MG/ML INJECTABLE INJECTION Discontinued —
CALCITRIOL
TEVAANDA 07576520012 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MCG CAPSULE ORAL Rx AB
0.5MCG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB
0.5MCG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MCG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Discontinued	—
0.5MCG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MCG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MCG	CAPSULE	ORAL	Rx	AB
0.25MCG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB
0.5MCG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB
0.5MCG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Rx	AP
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MCG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.001MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.002MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MCG	CAPSULE	ORAL	Rx	AB
0.5MCG	CAPSULE	ORAL	Rx	AB

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

Sep 25, 1986

40 yr 6 mo ago

Most recent approval

Feb 27, 2026

6 mo ago

Approvals span 1986–2026 across 23 FDA applications.

Brand (NDA) 417%

Generic (ANDA) 1983%

Calcitriol: 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.

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