Prescription drug · NDA
Widaplik NDC 24338-001
telmisartan, amlodipine and indapamide · Telmisartan 10 mg/1 + 2 more ingredients · Tablet · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-001-30 | 24338000130 | 30 TABLET in 1 BOTTLE (24338-001-30)Marketed from Oct 20, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Widaplik
- Generic name (nonproprietary)
- telmisartan, amlodipine and indapamide
- Active ingredients
- Telmisartan — 10 mg/1Amlodipine besylate — 1.25 mg/1Indapamide — .625 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219423
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 24338-001_e0af7498-0dc6-4a30-a103-e30ae36c794eSPL ID e0af7498-0dc6-4a30-a103-e30ae36c794eSPL set ID a30ff81d-420b-40ea-83d8-670260a93fffRxCUI 2727452, 2727458, 2727460, 2727462, 2727463, 2727465UNII 864V2Q084H, F089I0511L, U5SYW473RQUPC 0324338001301, 0324338002308, 0324338003305
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide-like Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N424338000130followed by a unit qualifier and the quantityPackage 24338-0001-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Widaplik (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. Contro…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 219423
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Widapliktelmisartan, amlodipine and indapamide | Telmisartan 40 mg/1 + 2 more ingredients | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-003 |
| Widapliktelmisartan, amlodipine and indapamide | Telmisartan 20 mg/1 + 2 more ingredients | TabletOral | Azurity Pharmaceuticals, Inc. | 24338-002 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.