Quick answers
- What is Granisetron used for?
- The FDA-approved label (Sancuso, Cumberland Pharmaceuticals Inc., November 4, 2024) says: “SANCUSO ® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. SANCUSO is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Granisetron have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Granisetron?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Granisetron been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Granisetron?
- 10 companies list prescription products of Granisetron in the FDA NDC Directory, including Mylan Institutional LLC, Eugia US LLC and Hikma Pharmaceuticals USA Inc..
What Granisetron is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SANCUSO ® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. SANCUSO is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days.
— FDA label: Sancuso, Cumberland Pharmaceuticals Inc., effective November 4, 2024. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| granisetron 3.1 mg/24 h patch | Brand: Sancuso | $686.64 per patch |
| granisetron hydrochloride 1 mg tablet | Generic | $1.28 per tablet |
| granisetron hydrochloride 1 mg tablet, film coated | Generic | $1.28 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Institutional LLC3 products
- Eugia US LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Intra-Sana Laboratories1 product
- Fresenius Kabi USA, LLC1 product
- Breckenridge Pharmaceutical, Inc.1 product
- Natco Pharma Limited1 product
- Bionpharma Inc.1 product
- Cumberland Pharmaceuticals Inc.1 product
- Heron Therapeutics, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022198 SANCUSO | Apotex | September 12, 2008 | 10, latest September 16, 2024 2024: Labeling · 2022: Manufacturing (CMC) · 2020: Labeling |
| NDA022445 SUSTOL | Heron Theraps Inc | August 9, 2016 | 2, latest February 23, 2026 2026: Labeling · 2023: Labeling |
Generic approvals (8)
- ANDA078678Orbion Pharms · February 13, 2008
- ANDA078096Fresenius Kabi USA · June 30, 2008
- ANDA078969Natco Pharma · June 22, 2009
- ANDA078629Hikma Farmaceutica · December 23, 2009
- ANDA091136Mylan Asi · April 9, 2010
- ANDA091137Mylan Asi · April 9, 2010
- ANDA204238Eugia Pharma · July 6, 2016
- ANDA219282Pharmobedient · March 17, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sancuso, Cumberland Pharmaceuticals Inc., effective November 4, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →