Is there a generic for Calcium gluceptate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Calcium gluceptate, referencing the brand CALCIUM GLUCEPTATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Calcium gluceptate?

CALCIUM GLUCEPTATE (NDA 006470, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Calcium gluceptate are approved?

Calcium gluceptate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Calcium gluceptate

Calcium gluceptate: 1 brand, 3 generics; first approved Apr 30, 1987; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CALCIUM GLUCEPTATE

LILLYNDA 006470—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 90MG CALCIUM/5ML	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (3)

CALCIUM GLUCEPTATE

ABRAXIS PHARMANDA 0893731987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 90MG CALCIUM/5ML	INJECTABLE	INJECTION	Discontinued	—

CALCIUM GLUCEPTATERLD

ABBOTTANDA 080001—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 90MG CALCIUM/5ML	INJECTABLE	INJECTION	Discontinued	—

CALCIUM GLUCEPTATE

ABBOTTANDA 083159—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 90MG CALCIUM/5ML	INJECTABLE	INJECTION	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

Apr 30, 1987

39 yr 9 mo ago

Most recent approval

Apr 30, 1987

39 yr 9 mo ago

All 4 applications were approved in 1987.

Brand (NDA) 125%

Generic (ANDA) 375%

Calcium gluceptate — 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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