Is there a generic for Cefpodoxime proxetil?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Cefpodoxime proxetil, referencing the brand VANTIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cefpodoxime proxetil?

VANTIN (NDA 050675, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cefpodoxime proxetil are approved?

Cefpodoxime proxetil is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Cefpodoxime proxetil

Cefpodoxime proxetil: 4 brands, 8 generics; first approved Aug 07, 1992; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 8 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

VANTINRLD

PFIZERNDA 05067519922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—
EQ 100MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—

VANTINRLD

PFIZERNDA 05067419922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

BANAN

SANKYONDA 05068819922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 50MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

BANAN

SANKYONDA 05068719922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 200MG BASE	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (8)

CEFPODOXIME PROXETIL

ALKEM LABS LTDANDA 21056820222 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 200MG BASE	TABLET	ORAL	Rx	AB

CEFPODOXIME PROXETIL

CHARTWELL RXANDA 09003120092 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 100MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEFPODOXIME PROXETIL

SANDOZANDA 06546220082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 200MG BASE	TABLET	ORAL	Rx	AB

CEFPODOXIME PROXETIL

ANDA REPOSITORYANDA 06538820072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 200MG BASE	TABLET	ORAL	Rx	AB

CEFPODOXIME PROXETIL

AUROBINDO PHARMAANDA 06537020072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 200MG BASE	TABLET	ORAL	Rx	AB

CEFPODOXIME PROXETIL

AUROBINDO PHARMA LTDANDA 06540920072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	—
EQ 100MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	—

CEFPODOXIME PROXETIL

SUN PHARM INDS LTDANDA 06508320032 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 200MG BASE	TABLET	ORAL	Discontinued	—

CEFPODOXIME PROXETIL

SUN PHARM INDS LTDANDA 06508220022 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 100MG BASE/5ML	FOR SUSPENSION	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

Aug 07, 1992

34 yr 5 mo ago

Most recent approval

May 18, 2022

4 yr 3 mo ago

Approvals span 1992–2022 across 12 FDA applications.

Brand (NDA) 433%

Generic (ANDA) 867%

Cefpodoxime proxetil — 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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