Is there a generic for Methyldopa?

Yes. The FDA Orange Book lists 43 approved generic (ANDA) applications for Methyldopa, referencing the brand ALDOMET. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methyldopa?

ALDOMET (NDA 013400, MERCK) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Methyldopa are approved?

Methyldopa is approved in the following dosage forms: suspension, tablet.

FDA Orange Book · active-ingredient family

Methyldopa

Methyldopa: 3 brands, 43 generics; first approved Jun 29, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 43 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

ALDOMETRLD
MERCKNDA 013400—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
METHYLDOPA
CHARTWELL RXNDA 01893419842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
500MG TABLET ORAL Discontinued —
ALDOMET
MERCKNDA 018389—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG/5ML SUSPENSION ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/5ML	SUSPENSION	ORAL	Discontinued	—

Generic (ANDA) products (43)

Abbreviated applications

METHYLDOPA
SUPERPHARMANDA 0706691989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
SUPERPHARMANDA 0706701989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
PLIVAANDA 0721261988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
PLIVAANDA 0721271988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
PLIVAANDA 0721281988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
HALSEYANDA 0717511988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
HALSEYANDA 0717521988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
HALSEYANDA 0717531988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
CHARTWELL RXANDA 0717001988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
QUAGENANDA 0705351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
QUAGENANDA 0705361987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
QUAGENANDA 0705371987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
DURAMED PHARMS BARRANDA 0710061986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
DURAMED PHARMS BARRANDA 0710091986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
TEVAANDA 0711051986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
TEVAANDA 0711061986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
TEVAANDA 0710671986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
SUN PHARM INDUSTRIESANDA 0700731986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
SUN PHARM INDUSTRIESANDA 0700601986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
SUN PHARM INDUSTRIESANDA 0700741986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0707031986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0706251986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
ROXANEANDA 0701921986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
ROXANEANDA 0701931986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
ROXANEANDA 0701941986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
PARKE DAVISANDA 0703311986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
PARKE DAVISANDA 0703321986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
PARKE DAVISANDA 0703331986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702451986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702461986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702471986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
HERITAGE PHARMAANDA 0700981986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
HERITAGE PHARMAANDA 0703431986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
PUREPAC PHARMANDA 0707491986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
PUREPAC PHARMANDA 0707501986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
PUREPAC PHARMANDA 0704521986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
ACCORD HLTHCAREANDA 0700701985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
ACCORD HLTHCAREANDA 0700841985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
ACCORD HLTHCAREANDA 0700851985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702601985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
125MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702611985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued —
METHYLDOPA
WATSON LABSANDA 0702621985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
METHYLDOPA
RISINGANDA 07007619852 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx —
250MG TABLET ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	—
250MG	TABLET	ORAL	Rx	—

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

Jun 29, 1984

42 yr 11 mo ago

Most recent approval

Jun 23, 1989

37 yr 10 mo ago

Approvals span 1984–1989 across 46 FDA applications.

Brand (NDA) 37%

Generic (ANDA) 4393%

Methyldopa: 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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