Is there a generic for Droperidol?

Yes. The FDA Orange Book lists 18 approved generic (ANDA) applications for Droperidol, referencing the brand INAPSINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Droperidol?

INAPSINE (NDA 016796, RISING) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Droperidol are approved?

Droperidol is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Droperidol

Droperidol: 1 brand, 18 generics; first approved Nov 17, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 18 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

INAPSINERLD
RISINGNDA 016796—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (18)

Abbreviated applications

DROPERIDOL
HIKMAANDA 2081972017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Rx AP
DROPERIDOL
HOSPIRAANDA 0722721995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
WATSON LABSANDA 0735201991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
WATSON LABSANDA 0735211991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
WATSON LABSANDA 0735231991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOLRS
AM REGENTANDA 0721231988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Rx AP
DROPERIDOL
LUITPOLDANDA 0723351988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
ASTRAZENECAANDA 0720181988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
IGI LABS INCANDA 0720191988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
IGI LABS INCANDA 0720201988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
IGI LABS INCANDA 0720211988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
SMITH AND NEPHEWANDA 0717501988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
SOLOPAKANDA 0717541988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
SOLOPAKANDA 0717551988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
HOSPIRAANDA 0716451988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
HOSPIRAANDA 0719811988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
ABRAXIS PHARMANDA 0709921986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —
DROPERIDOL
ABRAXIS PHARMANDA 0709931986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/ML	INJECTABLE	INJECTION	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

Nov 17, 1986

40 yr 4 mo ago

Most recent approval

Dec 14, 2017

8 yr 10 mo ago

Approvals span 1986–2017 across 19 FDA applications.

Brand (NDA) 15%

Generic (ANDA) 1895%

Droperidol: 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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