Medicine
Sincalide 5 mcg/5 mL powder for injection
Sincalide 5 mcg/5 mL powder for injection is a generic prescription medicine for intravenous use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25° C (77° F), excursions permitted to 15-30° C (59-86° F).
Key facts
- Active ingredient (INN)
- Sincalide
- Brand
- Sold under the generic name
- Strength
- 5 mcg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 5 vials, 10 vials
- Manufacturers
- Fosun PharmaFresenius KabiMAIA Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25° C (77° F), excursions permitted to 15-30° C (59-86° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V04CC03 Sincalide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 November 2022
- Identifiers
- RxCUI 237982DailyMed set ID bb5057da-8568-49b9-947d-fab7d8d8f257, efbc189e-f5f8-0ac7-e053-2995a90a68a9, 4149af34-7b3d-4200-9609-ea856b1d6aabNDC 63323-579, 72266-248, 70511-131Application NDA017697, NDA210850
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 vial in 1 package / 5 mL in 1 vial | 72266-248-05 | Fosun Pharma | 9 January 2023 |
| 10 vial in 1 package / 5 mL in 1 vial | 63323-579-05 | Fresenius Kabi | 1 April 2023 |
| 10 vial in 1 package / 5 mL in 1 vial | 70511-131-84 | MAIA Pharmaceuticals | 25 November 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 July 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Sincalide 5 mcg/5 mL powder for injection.
Clinical summary
Sincalide is a cholecystokinin analog indicated in adults to to stimulate gallbladder contraction, among other approved uses. MedsAcross supplies Sincalide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about SincalideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SINCALIDE prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Sincalide 5 mcg/5 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.