Prescription medicine
Sincalide Brand names: Kinevac
Sincalide (Kinevac) is a prescription medicine with an FDA approval on record since 1976. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sincalide FDA label on DailyMed (effective November 1, 2023, MAIA Pharmaceuticals, Inc.); the NDA 17697 record on Drugs@FDA; every sincalide label on DailyMed.
Highlights of the record
FDA label of November 1, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSincalide for Injection is indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals;
Forms and strengths
- 5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- July 21, 1976 Kinevac, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 0 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- April 20, 2038 Sincalide injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest April 13, 2022; 1 more by firms not listed as its makers
- FAERS reports
- 153 through July 30, 2026
What is sincalide used for?
From the label: indications and usageSincalide for Injection is indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. […]
FDA pharmacologic class: Cholecystokinin Analog.
Source: FDA drug label (Sincalide), MAIA Pharmaceuticals, Inc., effective November 1, 2023 (SPL set 4149af34-7b3d-4200-9609-ea856b1d6aab), via openFDA; the full label on DailyMed
Is there a generic for sincalide (Kinevac)?
No generic sincalide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Kinevac injection; a patent listed only for Sincalide injection runs to April 20, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1976 earliest approval on file
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sincalide been recalled?
The FDA's Enforcement Report lists 2 recalls naming sincalide since 2017: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sincalide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| November 16, 2017 | Class II | KRS Global Biotechnology, Inc not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for sincalide?
The FDA Adverse Event Reporting System holds 153 reports that list sincalide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 17 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sincalide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other