Quick answers
- What is Dasatinib used for?
- The FDA-approved label (Dasatinib, Prasco Laboratories, July 9, 2024) says: “Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dasatinib have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dasatinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dasatinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dasatinib?
- 17 companies list prescription products of Dasatinib in the FDA NDC Directory, including Teva Pharmaceuticals, Inc., Novadoz Pharmaceuticals LLC and E.R. Squibb & Sons, L.L.C..
What Dasatinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. …
— FDA label: Dasatinib, Prasco Laboratories, effective July 9, 2024. Read the full label on DailyMed →
The FDA has 13 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 13 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 |
|---|---|---|
| dasatinib 100 mg tablet | Generic | $24.09 per tablet |
| dasatinib 100 mg tablet | Brand: Sprycel | $591.18 per tablet |
| dasatinib 100 mg tablet, film coated | Generic | $24.09 per tablet |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and 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.
- Teva Pharmaceuticals, Inc.6 products
- Novadoz Pharmaceuticals LLC6 products
- E.R. Squibb & Sons, L.L.C.6 products
- Dr.Reddys Laboratories Inc6 products
- Prasco Laboratories6 products
- Biocon Pharma Inc.6 products
- Cycle Pharmaceuticals Ltd6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Lupin Pharmaceuticals, Inc.6 products
- AvKARE6 products
- Alembic Pharmaceuticals Limited6 products
- Aurobindo Pharma Limited6 products
- Apotex Corp.6 products
- Alembic Pharmaceuticals Inc.6 products
- BluePoint Laboratories6 products
- Zydus Lifesciences Limited6 products
- NorthStar RxLLC6 products
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 |
|---|---|---|---|
| NDA021986 SPRYCEL | Bristol Myers Squibb | June 28, 2006 | 23, latest October 16, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA216099 PHYRAGO | Handa Therap | December 5, 2023 | 4, latest October 16, 2026 2026: Labeling · 2025: Efficacy · 2024: Labeling |
Generic approvals (10)
- ANDA202103Apotex · June 10, 2016
- ANDA203180Apotex · November 23, 2021
- ANDA213383DR Reddys · March 3, 2025
- ANDA217217Biocon Pharma · March 3, 2025
- ANDA218719Zydus Pharms · March 3, 2025
- ANDA216547Eugia Pharma · April 22, 2025
- ANDA214350Lupin · August 25, 2025
- ANDA211094Teva Pharms USA · August 27, 2025
- ANDA216261Alembic · November 6, 2025
- ANDA219579Msn · September 11, 2026
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) — Dasatinib, Prasco Laboratories, effective July 9, 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 →