Is there a generic for Carboprost tromethamine?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Carboprost tromethamine, referencing the brand HEMABATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Carboprost tromethamine?

HEMABATE (NDA 017989, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Carboprost tromethamine are approved?

Carboprost tromethamine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Carboprost tromethamine

Carboprost tromethamine: 1 brand, 13 generics; first approved Jul 02, 2019; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 13 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

HEMABATERLDRS

PFIZERNDA 017989—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Abbreviated applications

Generic (ANDA) products (13)

CARBOPROST TROMETHAMINE

SOMERSET THERAPS LLCANDA 2195292026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

MICRO LABSANDA 2180132024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

ANI PHARMSANDA 2159012024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

CARBOPROST TROMETHAMINE

GLANDANDA 2176572023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

ONESOURCE SPECIALTYANDA 2168972023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

ALEMBICANDA 2171982023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

EUGIA PHARMAANDA 2169392023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

SOLA PHARMSANDA 2168242023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

CAPLINANDA 2168822023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

LONG GROVE PHARMSANDA 2144992022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

AMNEALANDA 2153372022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

SUNNYANDA 2131182021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CARBOPROST TROMETHAMINE

DR REDDYSANDA 2119412019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.25MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Jul 02, 2019

7 yr 2 mo ago

Most recent approval

May 27, 2026

2 mo ago

Approvals span 2019–2026 across 14 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1393%

Carboprost tromethamine — 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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