Prescription medicine
Amlodipine and indapamide and telmisartan Brand names: Widaplik
Amlodipine and indapamide and telmisartan (Widaplik) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the amlodipine and indapamide and telmisartan FDA label on DailyMed (effective July 3, 2026, Azurity Pharmaceuticals, Inc.); the NDA 219423 record on Drugs@FDA; every amlodipine and indapamide and telmisartan label on DailyMed.
Highlights of the record
FDA label of July 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Widaplik as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue WIDAPLIK as soon as possible ( 5.1 , 8.1 )
Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus
Used for
From the label: indications and usageWidaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure.
Forms and strengths
- 10 mg / 1.25 mg / 0.625 mg
- 20 mg / 2.5 mg / 1.25 mg
- 40 mg / 5 mg / 2.5 mg
Tablet.
On the market
- Earliest approval on file
- June 5, 2025 Widaplik, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 23, 2038 Widaplik tablets; 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)
- No recall recorded
What is amlodipine and indapamide and telmisartan used for?
From the label: indications and usageWidaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik. […]
Conditions named in the indications of amlodipine and indapamide and telmisartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker and Thiazide-like Diuretic.
Source: FDA drug label (WIDAPLIK), Azurity Pharmaceuticals, Inc., effective July 3, 2026 (SPL set a30ff81d-420b-40ea-83d8-670260a93fff), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and indapamide and telmisartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Widaplik?Widaplik can cause harm or death to an unborn baby. Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant during treatment with Widaplik, stop taking Widaplik and tell your healthcare provider right away.
From the patient leaflet: How should I store Widaplik?Store Widaplik tablets at room temperature between 68°F to 77°F (20°C to 25°C). Do not remove Widaplik tablets from bottle until right before you take them. Keep Widaplik tablets out of the light and away from moisture. Store Widaplik tablets in the original container. Keep Widaplik and all medicines out of the reach of children.
Source: FDA drug label (WIDAPLIK), Azurity Pharmaceuticals, Inc., effective July 3, 2026 (SPL set a30ff81d-420b-40ea-83d8-670260a93fff), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and indapamide and telmisartan (Widaplik)?
No generic amlodipine and indapamide and telmisartan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Widaplik tablets, the last expiring on January 23, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the amlodipine and indapamide and telmisartan label say about other medicines?
The amlodipine and indapamide and telmisartan label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer aliskiren with Widaplik in patients with diabetes [see Drug Interactions ( 7.1 )]. |
| Cyclosporine | drug interactions | Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Digoxin | drug interactions | When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. |
| Lithium | drug interactions | Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. |
| Sildenafil | drug interactions | Sildenafil Monitor for hypotension when sildenafil is co-administered with Widaplik. |
| Simvastatin | drug interactions | DRUG INTERACTIONS NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect ( 7.1 ) If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin ( 7.2 ) Do not co-administer aliskiren with Widaplik in patients with diabetes |
| Tacrolimus | drug interactions | Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
Check amlodipine and indapamide and telmisartan against other medicines
Source: FDA drug label (WIDAPLIK), Azurity Pharmaceuticals, Inc., effective July 3, 2026 (SPL set a30ff81d-420b-40ea-83d8-670260a93fff), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as amlodipine and indapamide and telmisartan?
61 other medicines are given the same way (oral) and in the same FDA class as amlodipine and indapamide and telmisartan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Hydrochlorothiazide and valsartan | High blood pressure | 18 labelers | $0.101 per tablet 160-12.5 mg tablet | No current entry |
| Chlorthalidone | High blood pressure | 36 labelers | $0.0743 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and indapamide and telmisartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and indapamide and telmisartan
- 61 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other