Is there a generic for Colestipol hydrochloride?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Colestipol hydrochloride, referencing the brand COLESTID. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Colestipol hydrochloride?

COLESTID (NDA 017563, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Colestipol hydrochloride are approved?

Colestipol hydrochloride is approved in the following dosage forms: granule, tablet.

FDA Orange Book · active-ingredient family

Colestipol hydrochloride

Colestipol hydrochloride: 2 brands, 7 generics; first approved Jul 19, 1994; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 7 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

COLESTIDRLD

PFIZERNDA 01756319954 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5GM/PACKET	GRANULE	ORAL	Discontinued	—
5GM/SCOOPFUL	GRANULE	ORAL	Discontinued	—
5GM/SCOOPFUL	GRANULE	ORAL	Rx	—
5GM/PACKET	GRANULE	ORAL	Rx	—

COLESTIDRLD

PFIZERNDA 0202221994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (7)

COLESTIPOL HYDROCHLORIDE

PHARMOBEDIENTANDA 2200122025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDE

RICONPHARMA LLCANDA 2174622024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDE

EDENBRIDGE PHARMSANDA 2176672024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDE

ANI PHARMSANDA 2165172023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDE

ZYDUS PHARMSANDA 2152232022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDERS

IMPAX LABSANDA 0775102006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	AB

COLESTIPOL HYDROCHLORIDE

IMPAX LABSANDA 07727720062 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5GM/SCOOPFUL	GRANULE	ORAL	Discontinued	—
5GM/PACKET	GRANULE	ORAL	Discontinued	—

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 19, 1994

32 yr 5 mo ago

Most recent approval

Sep 15, 2025

10 mo ago

Approvals span 1994–2025 across 9 FDA applications.

Brand (NDA) 222%

Generic (ANDA) 778%

Colestipol hydrochloride — 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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