FDA Orange Book · active-ingredient family
Calcium gluconate
Calcium gluconate: 2 brands, 7 generics; first approved Jun 15, 2017; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
7
Listed patents
2
Next patent expiry
Jul 25, 2037
in 11 yr 1 mo
Brand (NDA) products
Originator applications
- CALCIUM GLUCONATERLDRSHQ SPCLT PHARMANDA 21090620254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/50ML (20MG/ML) SOLUTION INTRAVENOUS Rx — 2GM/100ML (20MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx — - CALCIUM GLUCONATERLDRSFRESENIUS KABI USANDA 20841820175 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 5GM/50ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 1GM/50ML (20MG/ML) SOLUTION INTRAVENOUS Discontinued — 2GM/100ML (20MG/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- CALCIUM GLUCONATECAPLINANDA 21884020263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 5GM/50ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP - SAGENTANDA 21961920252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/50ML (20MG/ML) SOLUTION INTRAVENOUS Rx AP 2GM/100ML (20MG/ML) SOLUTION INTRAVENOUS Rx AP - CALCIUM GLUCONATEAMNEALANDA 21661120243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 5GM/50ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP - CALCIUM GLUCONATESOMERSETANDA 21768920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/50ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP - AMNEALANDA 21717420232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/50ML (20MG/ML) SOLUTION INTRAVENOUS Rx AP 2GM/100ML (20MG/ML) SOLUTION INTRAVENOUS Rx AP - CALCIUM GLUCONATEB BRAUN MEDICALANDA 2165412023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP - CALCIUM GLUCONATENIVAGEN PHARMS INCANDA 21307120223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 5GM/50ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP 10GM/100ML (100MG/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10130646 | in 11 yr 1 mo | Product | |
| 10342813 | in 11 yr 1 mo | Product |
Approval history
FDA approval span
First approval
9 yr 4 mo ago
Most recent approval
4 mo ago
Approvals span 2017–2026 across 9 FDA applications.
Brand (NDA) 222%
Generic (ANDA) 778%
Calcium gluconate: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
